regulatory specialist

DuPont

<div>
 At DuPont, our purpose is to empower the world with essential innovations to thrive. We work on things that matter. Whether it&rsquo;s providing clean water to more than a billion people on the planet, producing materials that are essential in everyday technology devices from smartphones to electric vehicles, or protecting workers around the world. Discover the many reasons the world&rsquo;s most talented people are choosing to work at DuPont. Why Join Us | DuPont Careers
 
 
 
 Quality responsibilities:
 
 
 
 <ul>
 <li>
 Ensures plant operating procedures and policies meet both ISO requirements and Water business quality/IMS requirements.
 </li>
 <li>
 Establishes and manages the plant QMS audit program in order to maintain ISO 9001Certification.
 </li>
 <li>
 Hosts and facilitates external audits for ISO 9001:2015, KIWA, NSF, Halal and Saudi Made
 </li>
 <li>
 Acts as the liaison between the Business, Plant and Site Quality System/ network working closely with the business quality functional leader (BQL).
 </li>
 <li>
 Manages customer complaints (product warranty claim) in SFDC tool and ensures effective RCI and corrective/preventive actions.
 </li>
 <li>
 Participates in the review of Plant&rsquo;s projects with potential impact on product quality.
 </li>
 <li>
 Supports qualification projects (i.e.: alternate raw material supplier, products transferred from Edina plant to Jubail plant, manufacturing equipment changes /improvements, testing equipment).
 </li>
 <li>
 Reviews risks on proposed changes as a reviewer in MOC process; submit MOCs for quality as needed.
 </li>
 <li>
 Tracks, investigates and reports &lsquo;quality unplanned events&rsquo; ensuring effective corrective and preventive actions.
 </li>
 <li>
 Coaches Operations Team (Technical Advisors/Lead Technicians/Production Engineers) to identify issues and improve product quality/Yield by using quality/six sigma tools/techniques.
 </li>
 <li>
 Assists with New Employee Training program.
 </li>
 <li>
 Provides quality reports to KSA Site leadership Team and Business Quality Leader.
 </li>
 <li>
 Audits plant&rsquo;s quality tracking systems (cell quality checks, autopsy results, DMR&rsquo;s, etc.) and follow-up on findings to ensure compliance with site policies /procedures/ operating discipline.
 </li>
 <li>
 Supports IMS Coordinator during Site Management System Review (facilitate MSR meetings as back-up)
 </li>
 <li>
 Must be willing to come in off shift for meetings and necessary site support.
 
 
 
 </li>
 </ul>
 
 Regulatory responsibilities:
 
 
 
 <ul>
 <li>
 Obtains adequate training from RO Product Steward in order to support Jubail site if/when needed.
 </li>
 <li>
 Guides the plant on both &lsquo;product&rsquo; and &lsquo;plant&rsquo; requirements to maintain NSF/KIWA/Halal certifications, and leads facility audits with these agencies
 </li>
 <li>
 Ensures new raw material(s) (i.e.: chemicals, components, and labels) meet Dupont regulatory and food contact requirement per RM drawings, in partnership with RO Business PSR and regional PSR.
 </li>
 <li>
 Maintains a qualified supplier list for the site (after an alternate RM Supplier is qualified for use by Jubail site); this will ensure visibility for yearly performance reviews of the site RM Suppliers
 </li>
 <li>
 Coordinates with RO Business PSR and/or EMEA PS to ensure consistency of practice to maintain certifications.
 </li>
 <li>
 Coordinates with product stewardship as needed to ensure consistency of practice to DuPont standards and local requirements.
 </li>
 <li>
 Ensures Product SDS and Label content is correct, and available in applicable languages.
 
 
 
 </li>
 </ul>
 
 Analytical responsibilities:
 
 
 
 <ul>
 <li>
 Work with and under the directions of the RO R&amp;D Analytical Specialist from Edina on analytical projects
 </li>
 <li>
 Ensure proper implementation of the analytical methods at KSA plant guiding Jubail&rsquo;s Analytical Chemist
 </li>
 <li>
 Assist Jubail&rsquo;s Analytical Chemist with validation of new testing method transferred from Edina and as necessary with qualification of new analytical testing equipment.
 </li>
 <li>
 Ensure proper training implementation at Jubail plant per RO R&amp;D Analytical Specialist guidelines.
 </li>
 <li>
 Assist Jubail&rsquo;s Analytical Chemist with troubleshooting per RO R&amp;D Analytical guidelines.
 </li>
 <li>
 Maintain adequate PM Program for the quality/analytical testing equipment/instruments in the plant.
 </li>
 <li>
 Lead the root cause investigations of &ldquo;out of spec&rdquo; analytical testing results and ensure &lsquo;out of spec&rsquo; results are not caused by the lab errors.
 </li>
 <li>
 Identify gaps and improvements needed in analytical testing/Jubail&rsquo;s Lab and work with RO R&amp;D Analytical Specialist to prioritize, charter and drive improvement projects forward to close gaps.
 
 
 
 </li>
 </ul>
 
 Qualifications:
 
 
 
 <ul>
 <li>
 4-year degree in Chemical/Mechanical Engineering
 </li>
 <li>
 Min 5 years of quality experience in manufacturing environment (desirable 7 years)
 </li>
 <li>
 Min 3 years supervisory experience
 </li>
 <li>
 Experience with Saudi Arabia regulatory requirements highly desired
 </li>
 <li>
 Experience with ISO 9001-2015 highly desired
 </li>
 <li>
 ISO 9001 Lead Auditor Certificate highly desired
 
 
 
 </li>
 </ul>
 
 Competency profile for this job:
 
 
 
 <ul>
 <li>
 Strong data analysis skills. Require learning JMP tool and Excel data functions to analyze and present SPC data. Capable of becoming Six Sigma certified.
 </li>
 <li>
 Capable to evaluate production data or experimental design data to isolate source of quality issues.
 </li>
 <li>
 Strong Interpersonal skills; must effectively interact with people from all departments at site level and across business. Communicate and resolve issues from manufacturing product failures to validated customer&rsquo;s complaints.
 </li>
 <li>
 Strong Leadership skills: must influence diverse workforce in areas of &lsquo;manage product quality&rsquo; and recommend improvements of the quality/integrated management system. Enlist support or direct resources across departments to identify/ isolate defective products.
 </li>
 <li>
 Good organizational skills: need to organize meetings to ensure alignment with site and supporting functions.
 </li>
 <li>
 Good problem-solving and time management skills: understands site/business goals/priorities and resources as well as production and shipment schedules.
 
 
 
 </li>
 </ul>
 Join our Talent Community to stay connected with us!
 
 
 DuPont is an equal opportunity employer. Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability or any other protected class. If you need a reasonable accommodation to search or apply for a position, please visit our Accessibility Page for Contact Information.
 
 
 DuPont offers a comprehensive pay and benefits package. To learn more visit the Compensation and Benefits page.
 
 
</div>

Site Quality and Regulatory Specialist

<div>At DuPont, our purpose is to empower the world with essential innovations to thrive. We work on things that matter. Whether it&rsquo;s providing clean water to more than a billion people on the planet, producing materials that are essential in everyday technology devices from smartphones to electric vehicles, or protecting workers around the world. Discover the many reasons the world&rsquo;s most talented people are choosing to work at DuPont. Why Join Us | DuPont Careers
Quality responsibilities:<ul><li>
Ensures plant operating procedures and policies meet both ISO requirements and Water business quality/IMS requirements.</li><li>
Establishes and manages the plant QMS audit program in order to maintain ISO 9001Certification.</li><li>
Hosts and facilitates external audits for ISO 9001:2015, KIWA, NSF, Halal and Saudi Made</li><li>
Acts as the liaison between the Business, Plant and Site Quality System/ network working closely with the business quality functional leader (BQL).</li><li>
Manages customer complaints (product warranty claim) in SFDC tool and ensures effective RCI and corrective/preventive actions.</li><li>
Participates in the review of Plant&rsquo;s projects with potential impact on product quality.</li><li>
Supports qualification projects (i.e.: alternate raw material supplier, products transferred from Edina plant to Jubail plant, manufacturing equipment changes /improvements, testing equipment).</li><li>
Reviews risks on proposed changes as a reviewer in MOC process; submit MOCs for quality as needed.</li><li>
Tracks, investigates and reports &lsquo;quality unplanned events&rsquo; ensuring effective corrective and preventive actions.</li><li>
Coaches Operations Team (Technical Advisors/Lead Technicians/Production Engineers) to identify issues and improve product quality/Yield by using quality/six sigma tools/techniques.</li><li>
Assists with New Employee Training program.</li><li>
Provides quality reports to KSA Site leadership Team and Business Quality Leader.</li><li>
Audits plant&rsquo;s quality tracking systems (cell quality checks, autopsy results, DMR&rsquo;s, etc.) and follow-up 
on findings to ensure compliance with site policies /procedures/ operating discipline.</li><li>
Supports IMS Coordinator during Site Management System Review (facilitate MSR meetings as back-up)</li><li>
Must be willing to come in off shift for meetings and necessary site support.</li></ul>
Regulatory responsibilities:<ul><li>
Obtains adequate training from RO Product Steward in order to support Jubail site if/when needed.</li><li>
Guides the plant on both &lsquo;product&rsquo; and &lsquo;plant&rsquo; requirements to maintain NSF/KIWA/Halal certifications, and leads facility audits with these agencies</li><li>
Ensures new raw material(s) (i.e.: chemicals, components, and labels) meet Dupont regulatory and food contact requirement per RM drawings, in partnership with RO Business PSR and regional PSR.</li><li>
Maintains a qualified supplier list for the site (after an alternate RM Supplier is qualified for use by Jubail site); this will ensure visibility for yearly performance reviews of the site RM Suppliers</li><li>
Coordinates with RO Business PSR and/or EMEA PS to ensure consistency of practice to maintain certifications.</li><li>
Coordinates with product stewardship as needed to ensure consistency of practice to DuPont standards and local requirements.</li><li>
Ensures Product SDS and Label content is correct, and available in applicable languages.</li></ul><div></div>
Analytical responsibilities:
<ul><li>Work with and under the directions of the RO R&amp;D Analytical Specialist from Edina on analytical projects</li><li>
Ensure proper implementation of the analytical methods at KSA plant guiding Jubail&rsquo;s Analytical Chemist</li><li>
Assist Jubail&rsquo;s Analytical Chemist with validation of new testing method transferred from Edina and as necessary with qualification of new analytical testing equipment.</li><li>
Ensure proper training implementation at Jubail plant per RO R&amp;D Analytical Specialist guidelines.</li><li>
Assist Jubail&rsquo;s Analytical Chemist with troubleshooting per RO R&amp;D Analytical guidelines.</li><li>
Maintain adequate PM Program for the quality/analytical testing equipment/instruments in the plant.</li><li>
Lead the root cause investigations of &ldquo;out of spec&rdquo; analytical testing results and ensure &lsquo;out of spec&rsquo; results are not caused by the lab errors.</li><li>
Identify gaps and improvements needed in analytical testing/Jubail&rsquo;s Lab and work with RO R&amp;D Analytical Specialist to prioritize, charter and drive improvement projects forward to close gaps.</li></ul>
Qualifications:<ul><li>
4-year degree in Chemical/Mechanical Engineering</li><li>
Min 5 years of quality experience in manufacturing environment (desirable 7 years)</li><li>
Min 3 years supervisory experience</li><li>
Experience with Saudi Arabia regulatory requirements highly desired</li><li>
Experience with ISO 9001-2015 highly desired</li><li>
ISO 9001 Lead Auditor Certificate highly desired</li></ul>
Competency profile for this job:
<ul><li>Strong data analysis skills. Require learning JMP tool and Excel data functions to analyze and present SPC data. Capable of becoming Six Sigma certified.</li><li>
Capable to evaluate production data or experimental design data to isolate source of quality issues.</li><li>
Strong Interpersonal skills; must effectively interact with people from all departments at site level and across business. Communicate and resolve issues from manufacturing product failures to 
validated customer&rsquo;s complaints.</li><li>
Strong Leadership skills: must influence diverse workforce in areas of &lsquo;manage product quality&rsquo; and recommend improvements of the quality/integrated management system. Enlist support or direct resources across departments to identify/ isolate defective products.</li><li>
Good organizational skills: need to organize meetings to ensure alignment with site and supporting functions.</li><li>
Good problem-solving and time management skills: understands site/business goals/priorities and resources as well as production and shipment schedules.
</li></ul>#LI-DK1
Join our Talent Community to stay connected with us!
DuPont is an equal opportunity employer. Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability or any other protected class. If you need a reasonable accommodation to search or apply for a position, please visit our Accessibility Page for Contact Information.
DuPont offers a comprehensive pay and benefits package. To learn more visit the Compensation and Benefits page.</div>

MicroAire Surgical Instruments

<div>MicroAire Surgical Instruments LLC
As a part of the global industrial organization Marmon Holdings&mdash;which is backed by Berkshire Hathaway&mdash;you&rsquo;ll be doing things that matter, leading at every level, and winning a better way. We&rsquo;re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone&rsquo;s empowered to be their best.
MicroAire Surgical Instruments, (Charlottesville, VA) is a wholly-owned subsidiary and one of five companies within the Medical Group of Marmon Holdings, a Berkshire Hathaway company. MicroAire is a mid-sized medical device solutions company with a 45-year legacy of quality and innovation. With well-recognized brands, the company is uniquely positioned as a leader in specialty markets, including minimally invasive medical devices and equipment for aesthetics/reconstruction, and endoscopic soft tissue release. MicroAire designs, manufactures, and markets cutting-edge medical devices that empower surgeons to push the boundaries of surgical precision, delivering safe, efficient, and high-quality patient outcomes.
About the Role
Shape global access. Safeguard compliance. 
MicroAire is seeking a Regulatory Intelligence Specialist to lead international product registrations and sustain regulatory compliance across worldwide markets. You&rsquo;ll own regulatory pathways, partner with distributors and authorities, and collaborate across the business to ensure patients worldwide can access our medical devices safely and compliantly. This is a hybrid in office and remote role. Ideal candidates will be local or willing to relocate.
What You&rsquo;ll Do<ul><li>
Lead international registrations: Procure, prepare, review, and submit documentation for new and existing product registrations in OUS markets.</li><li>
Own regulatory partnerships: Engage with Ministries of Health, Regulatory Bodies/Agencies, and distributors to support registration, reporting, and compliance.</li><li>
Ensure distributor compliance: Maintain an approved distributor list and verify CE marking, declarations of conformity, complaint handling, storage/transport controls, and cooperation with authorities.</li><li>
Advise on license holder strategy: Determine the appropriate regulatory license holder/owner in each market to support compliance and business goals.</li><li>
Make strategic decisions: Recommend optimal pathways for new submissions and product changes by market; anticipate regulatory impacts and advise leadership.</li><li>
Coordinate with MedEnvoy &amp; partners: Liaise with MedEnvoy (Importer of Record for Switzerland and partners for EU/UK) and the Swiss Authorized Representative to ensure required reports and filings are completed, as applicable.</li><li>
Monitor global changes: Stay ahead of evolving worldwide requirements; flag risks and propose solutions.</li><li>
Report &amp; collaborate: Create progress reports for leadership, contribute to quarterly plans, and support Product Development and fellow Regulatory Affairs Specialists as needed.</li></ul>
What We&rsquo;re Looking For<ul><li>
Bachelor&rsquo;s degree in a related field or equivalent experience.</li><li>
5+ years of medical device OUS registration experience.</li><li>
Experience with distributors and foreign regulatory authorities.</li><li>
RAC certification preferred; experience with FDA 510(k), EU MDR/CE Mark, or Health Canada is a plus.</li><li>
Strong organization, documentation, and problem&#8209;solving skills; proficiency with Microsoft Office.</li></ul>
Regulatory Expertise 
Strong knowledge of OUS medical device regulations, QMS standards (FDA QSR, ISO 13485, MDSAP), and international registration pathways.
Strategic &amp; Analytical Thinking 
Evaluates regulatory pathways, anticipates changes, balances compliance with business needs, and manages competing priorities.
Collaboration &amp; Communication 
Works effectively with internal teams and international partners; strong technical writing and ability to simplify complex regulatory topics.
Project Management &amp; Detail Orientation 
Manages multiple submissions, maintains accurate documentation, and drives process improvements.
Business Acumen 
Understands how regulatory requirements impact market access, operations, and commercial strategy.<div></div>
Why MicroAire?
Join a mission-driven team where your regulatory expertise directly supports global patient access, strategic growth, and product safety.
Our Benefits:
<ul><li>Competitive compensation</li><li>
401K with company match</li><li>
Medical/Dental/Vision</li><li>
Vacation &amp; Paid Holidays</li><li>
Connection with Marmon Holdings companywide initiatives</li></ul>
Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.
We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.</div>

Regulatory Intelligence Specialist

DEXIS

<div>
 
 Job Description
 
 
 
 Interprets federal/state/international regulations as they apply to our products, processes and/or procedures advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints. Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes. Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products. Executes appropriately on product recalls. Respond to regulatory agency inquiries. Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.
 
 
 
 Job Requirements
 
 
 
 
 Reports to Role
 
 : Head of RA Regions &amp; Registrations
 
 
 
 Location
 
 (HQ or Region, Country, Site):
 
 
 Istanbul, Turkey, EH TURKEY SA&Gbreve;LIK &Uuml;R&Uuml;NLER&Idot; VE H&Idot;ZMETLER&Idot; L&Idot;M&Idot;TED &Scedil;&Idot;RKET&Idot;. Fully remote
 
 
 
 
 PURPOSE
 
 
 
 &ndash; in a few sentences, briefly describe the overall purpose of the role, i.e. why the role exists
 
 
 
 The Regulatory Affairs Specialist supports regulatory affairs activities for international product registration by providing regulatory documentation and stakeholder support to ensure the timely regulatory approvals and maintenance of products in compliance with local regulatory requirements.
 
 
 The Regulatory Affairs Specialist is accountable for timely execution of regulatory strategies to support launch activities and maintain compliance status for international product registration.
 
 
 
 
 ACCOUNTABILITIES
 
 
 
 &ndash; describe role accountabilities/responsibilities, i.e. what the role does. Should cover the following:
 
 
 
 The Regulatory Affairs Specialist is accountable for compliance and delivery for all assigned countries and registrations in Regions.
 
 
 
 Regions &amp; Registrations
 
 
 
 <ul>
 <li>
 Contribute to development and execution of regulatory strategies for respective department projects, compliance projects as well as lifecycle management activities.
 </li>
 <li>
 Contribute to execution of International RA support projects for market access to REGIONS and ensure all RA related elements &amp; requirements implemented.
 </li>
 <li>
 Align with local distributors and with local RA, understand requirements, and assists with the deliverables/ files related to preparing ROW submissions; uploads deliverables/ files into repository. Consults with others on these efforts as required.
 </li>
 <li>
 Prepare, order, and maintain oversight of all Free Sales Certificates, Certificates of Foreign Government and Country of Origin certificates requested for international regulatory approvals
 </li>
 <li>
 Prepare core documentation "regulatory submission packages" for new product registrations in international markets
 </li>
 <li>
 Prepare country specific documents for international regulatory approvals including, but not limited to manufacturer statements, Letters of Authorization and Power of Attorney
 </li>
 <li>
 Review submission documents prepared by local RA to be used in country registrations
 </li>
 <li>
 Support provision of regulatory guidance for Nobel Biocare IFU and labeling processes
 </li>
 <li>
 Conduct regulatory release and delisting of products using specialized regulatory software
 </li>
 <li>
 Is aware of procedures and only makes decisions in line with procedure on simple topics
 </li>
 <li>
 Plan out workload to deliver on time, able to make adjustments when required and prioritizing work together with manager
 </li>
 <li>
 Prepare, and follow-up on International regulatory assessments for product changes
 </li>
 <li>
 Closely monitoring together with local country representatives guidelines, regulations, changes in the marketplace and regulator positions for the assigned markets to ensure new requirements are caught, impact assessed and escalated if required
 </li>
 <li>
 Close gaps created due to changed or new local country requirements by initatin projects and/or incorporating into global processes.
 </li>
 <li>
 Support the provision of regulatory guidance to project teams in assigned projects and markets, in terms of requirements and related submission to support optimal timelines and required compliance levels.
 </li>
 <li>
 Support the assembly of documents and the submission to authorities in countries of responsibility
 </li>
 <li>
 Supports the monitoring of the regulatory environment and maintenance of the information resources
 </li>
 <li>
 Support internal and external audits in the audit preparation and audit back office
 </li>
 <li>
 Contributes and participates in the review of change requests to ensure compliance and the potential for regulatory submissions
 </li>
 <li>
 May assist with reviews of promotional materials.
 </li>
 <li>
 Has a yearly training program in place specified by manager.
 </li>
 <li>
 Support the creation and maintenance of regulatory procedures and templates.
 </li>
 <li>
 Can revise or create Technical Files.
 </li>
 <li>
 Support the review of labels and IFUs
 </li>
 <li>
 Support provision of regulatory guidance for Nobel Biocare IFU and labeling processes
 </li>
 <li>
 Tracks and maintains files on current status of licenses, registrations and product information as per agreed formats in the different systems in use by the organization
 </li>
 <li>
 Can collect the regulatory compliance status of main countries, contribute to regulatory status of other regions of devices affected by HHE/Deviation/CAPA/Recall.
 </li>
 <li>
 Provide internal trainings on requirements for area under their responsibility.
 </li>
 <li>
 Knows and understands the EBS philosophy and employs it in daily RA activities and standard work.
 </li>
 <li>
 Able to provide input in terms of activities required to be added to a DM or VPM.
 </li>
 <li>
 Trained on PSP procedures to solve standard problems; analyzes information and standard practices to make judgments.
 
 
 </li>
 </ul>
 
 
 KNOWLEDGE, SKILLS &amp; EXPERIENCE
 
 
 
 &ndash;
 
 
 Functional/technical competencies specific to the role and required to perform the role
 
 
 
 
 Critical Knowledge and Qualifications:
 
 
 (what the role holder must know; including any required general or professional qualifications/education)
 
 
 
 <ul>
 <li>
 A minimum of a Bachelor&rsquo;s degree from accredited college or university is required.
 </li>
 <li>
 Basic knowledge of medical device quality management systems such as 21 CFR Part 820 and ISO 13485.
 </li>
 <li>
 Basic knowledge of international legislation in some countries.
 </li>
 <li>
 Knowledge of main general documents required as FSC &amp; legalization process
 
 
 </li>
 </ul>
 
 Critical Skills/technical know-how:
 
 
 (what the role holder must be able to do)
 
 
 
 <ul>
 <li>
 Fluency in English a must. Further languages is an advantage.
 </li>
 <li>
 Able to communicate effectively with team members, project team members, manager and other stakeholders; this includes: able to listen and grasp key information, able to clearly convey straightforward information, able to read non-verbal communication, such as reading body language and able to give short presentations to RA team on straightforward information
 </li>
 <li>
 Demonstrates and advocates for working together in the spirit of openness, honesty and transparency that encourages engagement, collaboration, respectful interactions and trust.
 </li>
 <li>
 Seeks out diverse ideas, opinions and insights, and applies them in workplace.
 </li>
 <li>
 Works closely with direct team and project teams and starts building up network of colleagues, stakeholders, SMEs and customers.
 </li>
 <li>
 Is aware of procedures and regulations and is able to assess situation on simple topics
 </li>
 <li>
 Creates clarity and direction amid complexity and develops solutions
 </li>
 <li>
 Never compromises on patient safety.
 </li>
 <li>
 Have a positive attitude and 'can do' spirit
 </li>
 <li>
 Ability to be flexible and adaptable. Maintain a professional demeanor under pressure.
 </li>
 <li>
 Demonstrate a commitment to getting the job done right and on time and prioritizing work together with manager.
 </li>
 <li>
 Be able to manage several projects, tasks products and/or countries work load and takes ownership.
 </li>
 <li>
 Have attention to detail to task in hand but also start seeing bigger picture / wider process.
 </li>
 <li>
 Know when to ask questions.
 
 
 </li>
 </ul>
 
 Critical Experience
 
 
 
 <ul>
 <li>
 Minimum 2 years' experience in regulatory affairs or associated field within medical device industry.
 
 
 </li>
 </ul>
 COMPETENCIES &ndash; Essential for the role
 
 
 
 Determine max. 6 competencies, refer to List and Definition of Competencies
 
 
 
 <ul>
 <li>
 Continuous Improvement
 </li>
 <li>
 Planning and Organizing
 </li>
 <li>
 Strategy execution
 </li>
 <li>
 Driving Execution
 </li>
 <li>
 Learning Orientation
 </li>
 <li>
 Actively contribute to successful team
 
 
 </li>
 </ul>
 
 Operating Company
 
 
 
 DEXIS
 
 
 Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.
</div>

Regulatory Affairs Specialist

AL Sharq Modern Trading

Regulatory Affairs Specialist &ndash; Job Description (Qatar)Position SummaryThe Regulatory Affairs Specialist is responsible for ensuring that all company products, operations, and activities comply with the regulatory requirements of the State of Qatar. This includes managing product registrations, approvals, certifications, renewals, and coordinating with government authorities such as the Ministry of Public Health (MOPH), Qatar Ministry of Commerce &amp; Industry (MOCI), Qatar Customs, Civil Defense, Baladiya (Municipality), and other relevant bodies.Key ResponsibilitiesRegulatory Compliance &amp; Documentation<ul><li>Prepare, review, and submit regulatory documents required for product approvals, import permits, and company licensing.</li><li>Register and renew products with MOPH (Pharmaceuticals, Medical Devices, Food, Cosmetics), Municipality, and other regulatory bodies.</li><li>Ensure product labels, safety data sheets, and brochures comply with Qatar&rsquo;s regulatory standards.</li><li>Maintain updated knowledge of Qatar laws, regulations, circulars, and procedures.</li></ul>Coordination with Authorities<ul><li>Liaise with government authorities including MOPH, MOCI, Baladiya, Karama, SASO/GSO (if GCC-related), and Qatar Customs.</li><li>Monitor and track the progress of submissions and approvals; follow up with authorities when necessary.</li></ul>Licensing &amp; Approvals<ul><li>Manage the renewal and compliance of company CR, trade licenses, regulatory approvals, and facility permits.</li><li>Ensure timely renewal of registration certificates, conformity certificates, and import/export authorizations.</li></ul>Internal Support<ul><li>Work closely with departments such as Quality, Logistics, Procurement, and Sales to ensure regulatory requirements are met before importing or selling products.</li><li>Guide the team on regulatory changes and new compliance requirements.</li><li>Support internal and external audits related to regulatory matters.</li></ul>Record Management<ul><li>Maintain systematic and accurate documentation of all regulatory files.</li><li>Create and update regulatory databases, trackers, and reports.</li></ul>Qualifications &amp; Requirements<ul><li>Bachelor&rsquo;s degree in Pharmacy, Biomedical Science, Chemistry, Engineering, or a related field.</li><li>Minimum 2&ndash;5 years of experience in Regulatory Affairs, preferably within Qatar.</li><li>Strong knowledge of Qatar MOPH, Baladiya, MOCI, and Customs regulations.</li><li>Excellent communication and report-writing skills.</li><li>High accuracy, attention to detail, and strong organization skills.</li><li>Proficient in Microsoft Office; experience with e-submission portals is a plus.</li><li>Ability to manage multiple tasks with tight deadlines.</li></ul>Preferred Skills<ul><li>Experience in medical devices, pharmaceuticals, cosmetics, food, or chemical product registration.</li><li>Strong coordination skills and ability to work independently.</li></ul>Work Environment<ul><li>Office-based role with visits to MOPH, Municipality, Customs, Civil Defense, and other regulatory entities when required.</li><li>Regular interaction with internal departments and external authorities.</li></ul>Job Types: Full-time, PermanentPay: From QAR3,000.00 per month

UTOPIA INDUSTRIES PVT LTD

Regulatory Compliance Officer/ Specialist &ndash; Dietary SupplementsEducation: Bachelor&rsquo;s/Master&rsquo;s degree in Pharmacy, Food Science, Nutrition, Biotechnology, or Regulatory Affairs.Experience: Minimum 3&ndash;5 years in product regulatory compliance, preferably in dietary supplements, cosmetics, or nutraceuticals.KeyResponsibilities:<ul><li>Ensure all dietary supplements comply with U.S. FDA Dietary Supplement regulations under the FD&amp;C Act and 21 CFR 111 (cGMP).</li><li>Review and verify supplier documentation, including Certificates of Analysis (COA), GMP certificates, NDI notifications, product dossiers, permitted ingredients, prohibited or restricted ingredients and formulation specifications.</li><li>Ensure scientific substantiation of ingredient functions and claims.</li><li>Review all product labels, claims and Amazon listings for compliance with FDA labeling guidelines (identity statement, net quantity, Supplement Facts, ingredient declaration, warnings).</li><li>Communicate with suppliers to ensure documentation completeness, GMP certification, facility registration, and FDA establishment listing and product conformity.</li><li>Evaluate supplier test data for microbial, heavy metals, and purity compliance.</li><li>Ensure all required premarket notifications (e.g., NDIN, if applicable) are filed or confirmed by the supplier, manage product listing on Amazon and FDA notification (via SPL) if needed.</li><li>Oversee post-market vigilance, including consumer complaint tracking, recall coordination, and adverse event reporting.</li><li>Work closely with QA/QC, Procurement, and Marketing teams to integrate regulatory compliance early in product selection.</li><li>Support packaging and labeling approval cycles before production.</li></ul>Job Type: Full-timeWork Location: In person

Amerikan Hastanesi

<div>
 
 Stembio (
 
 Ko&ccedil; Holding/Ko&ccedil; Healthcare
 
 i&scedil;tiraki),
 
 Mezenkimal K&ouml;k H&uuml;creler (MSC), Eksozomlar, &Idot;mm&uuml;noterapi &Uuml;r&uuml;nleri, Kordon Kan&inodot; Bankalama ve Doku Greftleri
 
 &uuml;retimi ve haz&inodot;rlanmas&inodot; konusunda uzmanla&scedil;m&inodot;&scedil;, ileri teknolojiye sahip bir
 
 cGMP laboratuvar&inodot;d&inodot;r
 
 . Kalite kontrol ve validasyon s&uuml;re&ccedil;lerine b&uuml;y&uuml;k &ouml;nem vererek,
 
 y&uuml;ksek kaliteli ve reg&uuml;lasyonlara uygun
 
 h&uuml;cresel tedavi &uuml;r&uuml;nleri sunmay&inodot; taahh&uuml;t ediyoruz.
 
 
 
 
 
 Yenilik&ccedil;i &uuml;r&uuml;n portf&ouml;y&uuml;m&uuml;zde &mdash; ATMP&rsquo;ler, t&inodot;bbi cihazlar ve kozmetik s&inodot;n&inodot;f biyolojik &uuml;r&uuml;nler dahil &mdash; reg&uuml;lasyon stratejilerini y&uuml;r&uuml;tecek ve destekleyecek, erken geli&scedil;tirme a&scedil;amas&inodot;ndan klinik &ccedil;al&inodot;&scedil;ma izinlerine ve &uuml;r&uuml;n ticarile&scedil;tirmeye kadar t&uuml;m s&uuml;re&ccedil;lerde T&Idot;TCK, ard&inodot;ndan EMA (Avrupa) ve FDA (ABD) &ccedil;er&ccedil;evelerine uygun reg&uuml;lasyon uyumlulu&gbreve;unu sa&gbreve;lamaktan sorumlu
 
 Stembio
 
 'da g&ouml;revlendirilmek &uuml;zere bir
 
 Reg&uuml;lasyon Uzman&inodot;
 
 aray&inodot;&scedil;&inodot;nday&inodot;z.
 
 
 
 
 
 E&gbreve;er Ar-Ge, Kalite ve &Uuml;retim ekipleriyle yak&inodot;n i&scedil; birli&gbreve;i i&ccedil;inde &ccedil;al&inodot;&scedil;arak Stembio &uuml;r&uuml;nlerinin uluslararas&inodot; standartlara uygun ve hem yerel hem k&uuml;resel pazarlara haz&inodot;r hale getirilmesi konusunda yetkin oldu&gbreve;unuzu d&uuml;&scedil;&uuml;n&uuml;yorsan&inodot;z, ba&scedil;vurunuzu bekliyoruz!
 
 
 
 
 
 
 Genel Nitelikler
 
 
 
 
 
 <ul>
 <li>
 Biyolojik Bilimler, Biyoteknoloji, Eczac&inodot;l&inodot;k, Biyomedikal M&uuml;hendisli&gbreve;i, Kimya veya ilgili bir alanda lisans veya &uuml;zeri derece.
 </li>
 <li>
 Tercihen biyoteknoloji, ila&ccedil; veya t&inodot;bbi cihaz sekt&ouml;rlerinde en az 5 y&inodot;l Reg&uuml;lasyon alan&inodot;nda deneyim.
 </li>
 <li>
 ATMP, GMP, CE i&scedil;areti, MDR/IVDR ve klinik &ccedil;al&inodot;&scedil;ma d&uuml;zenlemeleri hakk&inodot;nda sa&gbreve;lam bilgi.
 </li>
 <li>
 K&uuml;resel reg&uuml;lasyon &ccedil;er&ccedil;evelerine h&acirc;kimiyet:
 </li>
 </ul>
 
 
 
 
 
 T&uuml;rkiye:
 
 T&Idot;TCK (ATMP ve cihaz kay&inodot;tlar&inodot;, klinik &ccedil;al&inodot;&scedil;ma izinleri
 
 
 
 Avrupa:
 
 EMA (CAT, EudraCT, EudraVigilance)
 
 
 
 K&uuml;resel:
 
 FDA (CBER), ICH k&inodot;lavuzlar&inodot;, ISO standartlar&inodot;
 
 
 
 
 <ul>
 <li>
 &Uuml;r&uuml;n kay&inodot;t dosyalar&inodot;, teknik belgeler ve klinik dok&uuml;mantasyon haz&inodot;rlama deneyimi.
 </li>
 <li>
 T&uuml;rk&ccedil;e ve &Idot;ngilizce yaz&inodot;l&inodot;/s&ouml;zl&uuml; ileti&scedil;im becerileri g&uuml;&ccedil;l&uuml;.
 </li>
 <li>
 &Ccedil;ok disiplinli ekiplerle &ccedil;al&inodot;&scedil;abilen, &ouml;ncelik y&ouml;netimi kuvvetli, dinamik ortamlarda etkin &ccedil;al&inodot;&scedil;abilen.
 </li>
 <li>
 Etik de&gbreve;erlere sahip, d&uuml;zenli, detaylara &ouml;nem veren ve reg&uuml;lasyon bilimi ile yenili&gbreve;e tutkulu.
 </li>
 </ul>
 
 
 
 
 
 Rol ve Sorumluluklar
 
 
 
 
 
 
 
 Reg&uuml;lasyon Stratejisi ve &Uuml;r&uuml;n Geli&scedil;tirme
 
 
 
 
 
 <ul>
 <li>
 Stembio&rsquo;nun &uuml;r&uuml;n portf&ouml;y&uuml; i&ccedil;in reg&uuml;lasyon stratejilerini geli&scedil;tirmek ve uygulamak.
 </li>
 <li>
 Klinik &ccedil;al&inodot;&scedil;ma onaylar&inodot;, GMP sertifikasyonlar&inodot; ve ruhsat ba&scedil;vurular&inodot;n&inodot; (T&Idot;TCK, EMA, FDA) planlamak ve y&ouml;netmek.
 </li>
 <li>
 Ba&scedil;vuru ve onay takvimlerini belirleyerek, i&ccedil; ekiplerle koordinasyon i&ccedil;inde hedeflenen lansman tarihlerine ula&scedil;&inodot;lmas&inodot;n&inodot; sa&gbreve;lamak.
 </li>
 <li>
 K&uuml;resel &uuml;r&uuml;n dosyalar&inodot;n&inodot; yerel reg&uuml;lasyon formatlar&inodot;na uyarlamak ve gerekli ek dok&uuml;mantasyonu haz&inodot;rlamak.
 </li>
 <li>
 Yeni endikasyonlar, teknoloji transferleri ve i&scedil; birlikleri i&ccedil;in reg&uuml;lasyon due diligence &ccedil;al&inodot;&scedil;malar&inodot;na destek vermek.
 </li>
 </ul>
 
 
 
 
 
 Reg&uuml;lasyon Uyumu ve Kurumsal &Idot;leti&scedil;im
 
 
 
 
 
 <ul>
 <li>
 T&uuml;rkiye, Avrupa Birli&gbreve;i ve ABD&rsquo;deki ATMP, t&inodot;bbi cihaz ve kozmetik mevzuatlar&inodot;ndaki geli&scedil;meleri takip etmek ve yorumlamak.
 </li>
 <li>
 Reg&uuml;lasyon kurumlar&inodot;yla (T&Idot;TCK, EMA, FDA, Onaylanm&inodot;&scedil; Kurulu&scedil;lar) aktif ileti&scedil;im y&uuml;r&uuml;tmek, denetimlerde ve incelemelerde Stembio&rsquo;yu temsil etmek.
 </li>
 <li>
 GMP ve reg&uuml;lasyon denetimlerine y&ouml;nelik haz&inodot;r olma durumunu sa&gbreve;lamak, denetim cevaplar&inodot;n&inodot; ve CAPA s&uuml;re&ccedil;lerini y&ouml;netmek.
 </li>
 <li>
 T&uuml;rkiye ve AB&rsquo;de ATMP alan&inodot;ndaki reg&uuml;lasyon &ccedil;er&ccedil;evesini &scedil;ekillendiren sekt&ouml;r giri&scedil;imlerinde aktif rol almak.
 </li>
 </ul>
 
 
 
 
 
 Standartlar, Sertifikasyon ve Dok&uuml;mantasyon
 
 
 
 
 
 <ul>
 <li>
 Ge&ccedil;erli uluslararas&inodot; standartlara (ISO 13485, ISO 10993, EN, IEC, ICH Q serisi) ve y&ouml;netmeliklere (CE i&scedil;areti, MDSAP, MDR, IVDR) uygunlu&gbreve;u sa&gbreve;lamak.
 </li>
 <li>
 &Uuml;r&uuml;n kay&inodot;t dosyalar&inodot;, teknik dok&uuml;mantasyon, etiketleme ve kullan&inodot;m k&inodot;lavuzlar&inodot;n&inodot; haz&inodot;rlamak, g&ouml;zden ge&ccedil;irmek ve g&uuml;ncel tutmak.
 </li>
 <li>
 Sertifikasyon s&uuml;re&ccedil;lerini (&ouml;r. CE, TSE, Eurovent, PED) koordine etmek; akredite test laboratuvarlar&inodot; ve sertifikasyon kurulu&scedil;lar&inodot;yla ileti&scedil;imi y&uuml;r&uuml;tmek.
 </li>
 </ul>
 
 
 
 
 
 Klinik &Ccedil;al&inodot;&scedil;malar ve Pazar Sonras&inodot; Faaliyetler
 
 
 
 
 
 <ul>
 <li>
 Klinik &ccedil;al&inodot;&scedil;ma ba&scedil;vurular&inodot;, tadilatlar&inodot; ve yenilemelerini T&Idot;TCK ve EMA &ccedil;er&ccedil;evelerinde desteklemek.
 </li>
 <li>
 ATMP&rsquo;lere y&ouml;nelik k&uuml;resel klinik ara&scedil;t&inodot;rma ortam&inodot;n&inodot; takip etmek ve Klinik &Ccedil;al&inodot;&scedil;ma Yetkilendirmesi (CTA) dosyalar&inodot;n&inodot;n haz&inodot;rlanmas&inodot;na katk&inodot; sa&gbreve;lamak.
 </li>
 <li>
 Onayl&inodot; &uuml;r&uuml;nler i&ccedil;in pazar sonras&inodot; g&ouml;zetim, g&uuml;venlilik raporlamas&inodot; ve s&uuml;rekli emniyet g&uuml;ncellemelerini y&uuml;r&uuml;tmek.
 </li>
 </ul>
 
 
 
 
 
 &Idot;&ccedil; Kalite ve S&uuml;re&ccedil; Entegrasyonu
 
 
 
 
 
 <ul>
 <li>
 Reg&uuml;lasyon ve GMP standartlar&inodot;na uygunlu&gbreve;u sa&gbreve;lamak &uuml;zere i&ccedil; denetimler ger&ccedil;ekle&scedil;tirmek.
 </li>
 <li>
 Kalite G&uuml;vence, Ar-Ge, &Uuml;retim ve Hukuk ekipleriyle i&scedil; birli&gbreve;i i&ccedil;inde &uuml;r&uuml;n ya&scedil;am d&ouml;ng&uuml;s&uuml;n&uuml;n her a&scedil;amas&inodot;nda reg&uuml;lasyon entegrasyonunu sa&gbreve;lamak.
 </li>
 <li>
 Uyumsuzluk risklerini tespit etmek ve proaktif &ouml;nleme stratejileri geli&scedil;tirmek.
 </li>
 </ul>
 
 
 
 
 
 Ki&scedil;isel verileriniz, i&scedil; ba&scedil;vurunuzun al&inodot;nmas&inodot; ve de&gbreve;erlendirmesi amac&inodot;yla i&scedil;lenmektedir. &Idot;&scedil;lenen ki&scedil;isel verilerinize ve haklar&inodot;n&inodot;za ili&scedil;kin detayl&inodot; bilgilere websitemizin &ldquo;&Idot;nsan Kaynaklar&inodot;&rdquo; ba&scedil;l&inodot;&gbreve;&inodot; i&ccedil;erisinde yer alan&ldquo;&Ccedil;al&inodot;&scedil;an Aday&inodot; Ayd&inodot;nlatma Metni&rsquo;nden ula&scedil;abilirsiniz.
 
 
 
 
 
 
 -------------------------------------------------------------------------------------------------------------
 
 
 
 
 
 Stembio (a Koc Holding/Koc Healthcare company) is a cutting-edge cGMP laboratory specializing in the production and preparation of Mesenchymal Stem Cells (MSCs), Exosomes, Immunotherapy Products, Cord Blood Banking, and Tissue Grafts. We are committed to delivering high-quality, regulatory-compliant cell therapy products through rigorous quality control and validation processes.
 
 
 
 
 
 We are seeking for a qualified and experienced
 
 Regulatory Affairs Specialist
 
 
 for Stembio,
 
 who
 
 
 will be responsible for ensuring regulatory compliance from early development to clinical trial authorization and product commercialization, initially under Turkish Medicines and Medical Devices Agency (T&Idot;TCK), and subsequently through EMA (Europe) and FDA (U.S.) frameworks,
 
 
 to lead and support regulatory strategies across Stembio&rsquo;s innovative product lines &mdash; including ATMPs, medical devices, and cosmetic-grade biologics.
 
 
 
 
 
 If you are passionate about creating close collaboration with R&amp;D, Quality, and Production teams to ensure Stembio&rsquo;s products meet international standards and are launch-ready for both local and global markets, we encourage you to apply!
 
 
 
 
 
 
 Qualifications
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s or higher degree in Biological Sciences, Biotechnology, Pharmacy, Biomedical Engineering, Chemistry, or a related discipline.
 </li>
 <li>
 Minimum 5 years of experience in Regulatory Affairs, ideally within the biotechnology, pharmaceutical, or medical device sectors.
 </li>
 <li>
 Solid understanding of ATMP, GMP, CE marking, MDR/IVDR, and clinical trial regulations.
 </li>
 <li>
 Familiarity with global regulatory frameworks:
 </li>
 </ul>
 
 
 
 
 
 T&uuml;rkiye:
 
 T&Idot;TCK (ATMP and Device Registration, Clinical Trial Authorization)
 
 
 
 Europe:
 
 EMA (CAT, EudraCT, EudraVigilance)
 
 
 
 Global:
 
 FDA (CBER), ICH guidelines, ISO standards
 
 <ul>
 <li>
 Experience in preparing and maintaining product registration files, technical documentation, and clinical dossiers.
 </li>
 <li>
 Strong communication skills in Turkish and English (both written and spoken).
 </li>
 <li>
 Ability to work effectively in cross-functional teams and manage multiple priorities in a dynamic environment.
 </li>
 <li>
 Ethical, organized, and detail-oriented mindset with a passion for regulatory science and innovation.
 </li>
 </ul>
 
 
 
 
 
 Key Responsibilities
 
 
 
 
 
 
 
 Regulatory Strategy &amp; Product Development
 
 
 
 
 
 <ul>
 <li>
 Develop and execute regulatory strategies for Stembio&rsquo;s Product Pipeline.
 </li>
 <li>
 Plan and manage regulatory submissions for clinical trial approvals, GMP certifications, and marketing authorizations under T&Idot;TCK, EMA, and FDA.
 </li>
 <li>
 Define submission and approval timelines, coordinating with internal teams to meet launch targets.
 </li>
 <li>
 Adapt global product dossiers to local regulatory formats and gather supplementary documentation as needed.
 </li>
 <li>
 Support regulatory due diligence for new indications, technology transfers, and collaborations.
 </li>
 </ul>
 
 
 
 
 
 Regulatory Compliance &amp; Institutional Liaison
 
 
 
 
 
 <ul>
 <li>
 Monitor and interpret evolving legislation on ATMPs, medical devices, and cosmetics across T&uuml;rkiye, EU, and the U.S.
 </li>
 <li>
 Maintain active communication with regulatory bodies (T&Idot;TCK, EMA, FDA, Notified Bodies) and represent Stembio during inspections and audits.
 </li>
 <li>
 Ensure inspection-readiness for GMP and regulatory audits; manage audit responses and CAPAs.
 </li>
 <li>
 Engage with industry associations to support advocacy initiatives shaping the Turkish and EU ATMP landscape.
 </li>
 </ul>
 
 
 
 
 
 Standards, Certification &amp; Documentation
 
 
 
 
 
 <ul>
 <li>
 Ensure compliance with applicable international standards (ISO 13485, ISO 10993, EN, IEC, ICH Q-series) and directives (CE marking, MDSAP, MDR, IVDR).
 </li>
 <li>
 Prepare, review, and maintain technical documentation, including product registration files, device master records, labeling, and instructions for use.
 </li>
 <li>
 Coordinate certification processes (e.g., CE, TSE, Eurovent, PED) and liaise with accredited test laboratories and certification bodies.
 </li>
 </ul>
 
 
 
 
 
 Clinical Trials &amp; Post-Market Activities
 
 
 
 
 
 <ul>
 <li>
 Support clinical trial submissions, amendments, and renewals under T&Idot;TCK and EMA frameworks.
 </li>
 <li>
 Track the global clinical trial landscape for ATMPs and contribute to dossier compilation for Clinical Trial Authorization (CTA).
 </li>
 <li>
 Oversee post-market surveillance, vigilance reporting, and continuous safety updates for approved products.
 </li>
 </ul>
 
 
 
 
 
 Internal Quality &amp; Process Integration
 
 
 
 
 
 <ul>
 <li>
 Conduct internal audits to ensure adherence to regulatory and GMP standards.
 </li>
 <li>
 Collaborate with Quality Assurance, R&amp;D, Production, and Legal teams to ensure full regulatory integration across the product lifecycle.
 </li>
 <li>
 Identify compliance risks and develop proactive mitigation strategies.
 </li>
 </ul>
 
 
 
 
 
 Your personal data is processed for the purpose of receiving and evaluating your job application. You can find detailed information about your processed personal data and rights from the "Employee Candidate Clarification Text" under the "Human Resources" heading of our website.
 
 
</div>

Stembio - Regülasyon Uzmanı / Regulatory Affairs Specialist

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Stembio - Regülasyon Uzmanı / Regulatory Affairs Specialist