regulatory specialist

Salt

<div>
 
 
 🤖 Legal &amp; Regulatory Specialist
 
 
 
 
 ⏳ 6-month initial contract - with extensions
 
 
 
 
 📍 Qatar
 
 
 
 
 💥 Visa &amp; healthcare are provided for the
 
 candidate only
 
 
 
 
 
 
 
 I am working with Big 4 Consultancy, who are looking for a
 
 Legal &amp; Regulatory Expert
 
 to join their team. The successful candidate will play a key role in shaping and maintaining regulatory frameworks, ensuring compliance, and supporting the institution in achieving alignment with both regional and international standards.
 
 
 
 
 
 
 Key Responsibilities:
 
 
 <ul>
 <li>
 Review, draft, and harmonize rules, policies, and guidance related to market conduct, issuers, and listed companies.
 </li>
 <li>
 Act as the primary legal liaison with institutional leadership and external stakeholders.
 </li>
 <li>
 Prepare and manage consultation materials, representing the institution in legislative and joint committees.
 </li>
 <li>
 Ensure regulatory coherence and compliance with regional and international standards.
 </li>
 </ul>
 
 
 
 
 
 Requirements:
 
 
 <ul>
 <li>
 Proven experience in legal and regulatory advisory within financial services or capital markets.
 </li>
 <li>
 Strong understanding of market conduct, compliance frameworks, and corporate governance.
 </li>
 <li>
 Excellent drafting, analytical, and communication skills.
 </li>
 <li>
 Fluency in
 
 Arabic and English
 
 is mandatory.
 </li>
 <li>
 Financial services experience.
 </li>
 </ul>
 
 
 
 
 Please apply to be contacted with further information.
 
</div>

Legal & Regulatory Specialist

<div>Site Name: Egypt - Cairo, Poznan Grunwaldzka 
Posted Date: Nov 13 2025 
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&amp;D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people&rsquo;s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients&rsquo; needs and have the highest probability of success. We&rsquo;re uniting science, technology, and talent to get ahead of disease together. 
Find out more: 
Our approach to R&amp;D
Senior Regulatory Specialist, Small Molecules Mature Products, CMC, Global Regulatory Affairs &ndash; Delivery Team
Are you looking for an opportunity to work on global projects and make a meaningful impact in the pharmaceutical industry?
Join the Delivery Team within SMMP at GSK and play a crucial role in global Chemistry, Manufacturing, and Control (CMC) variation projects and Global Supply Chain (GSC) change programs for pharmaceutical products. You&rsquo;ll be responsible for ensuring timely and efficient delivery of regulatory activities across multiple CMC projects within Pharma business. You&rsquo;ll be responsible for preparing technical documentation for global regulatory changes, responding to Regulatory Agency inquiries, and providing expert guidance on CMC variations for Active Pharmaceutical Ingredients (APIs), Intermediates, and Drug Products.
In this role, you&rsquo;ll collaborate with diverse teams across Global Regulatory Organization, Global Supply Chain, Quality Assurance, Contract Manufacturing Organizations, and the Office of the Chief Medical Officer (OCMO) to produce high-quality components for global regulatory dossiers. Additionally, you&rsquo;ll have the opportunity to mentor and train new team members, contributing to the growth and success of the team.
In this role you will&hellip;<ul><li>
Managing multiple project assignments simultaneously, including CMC variations, source transfers, and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Pharma products (working with the CTD Module 3, Quality section of the dossiers).</li><li>
Managing assigned projects by executing agreed dossier strategies, completing data assessments to ensure dossiers are fit for purpose and in compliance with GSK regulatory processes and external requirements for local markets (e.g., Europe, US, and International countries), and identifying risks associated with submission data and information packages.</li><li>
Preparing and coordinating the review and approval of submission-ready documents.</li><li>
Collaborating with Product Owners/Project Managers to provide regulatory support for assigned projects.</li><li>
Working with colleagues in the Global Supply Chain, Global Regulatory Groups, and GSK Local Operating Companies in markets worldwide to deliver high-quality dossiers on time.</li><li>
Building and maintaining strong relationships with internal and external stakeholders.</li><li>
Monitoring regulatory intelligence and proactively acting on identified changes to regulatory requirements.</li><li>
Identifying improvement opportunities for CMC regulatory processes, policies, and systems.</li></ul>
Why you?
 Basic Qualifications &amp; Skills:
We are seeking professionals with the following required skills and qualifications to help us achieve our roles:<ul><li>
Bachelor&rsquo;s or Master&rsquo;s degree in biotechnology, chemical technology, pharmacy, chemistry, or another related science or technical field.</li><li>
Relevant experience in regulatory affairs (the pharmaceutical industry), with familiarity in post-approval CMC regulatory procedures and ICH CTD documentation (Modules 2 and 3).</li><li>
Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.</li><li>
Thorough understanding of change management processes and regulatory requirements.</li><li>
Attention to detail with an emphasis on accuracy and completeness.</li><li>
Ability to handle multiple tasks, meet shifting priorities, and schedule work to meet business needs.</li><li>
Flexible and analytical thinking to independently provide solutions to issues.</li><li>
Excellent interpersonal skills, including the ability to communicate clearly and effectively, work in a diverse team environment, and build relationships across a large organization.</li><li>
Excellent written and verbal communication skills in English.</li></ul> 
Why GSK? 
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases &ndash; to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we&rsquo;re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Contact information: 
You may apply for this position online by selecting the Apply now button.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.</div>

Senior Regulatory Specialist

Roche

<div>At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.<div>
The Position</div>
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people&rsquo;s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters. 
 
The Position 
We are looking for a Regulatory Affairs and Quality Specialist at Roche Diagnostics. 
 What will you do?<ul><li> 
You ensure all product related local and global requirements for registration.</li><li> 
You supervise all kinds of registration procedures of the products, to obtain documentation related there of from company&rsquo;s relevant global functions. Mastery of all IVD product local registration processes and coordination with functions such as product management, sales and tenders.</li><li> 
You coordinate regulatory documentation activities, obtain overseas documents required for tenders and other legal procedures and participate meetings with regulatory body when necessary.</li><li> 
You update and maintain the quality assurance system aligned with global standards and local requirements.</li><li> 
You work together with distributors in the quality assurance area and to perform controlling processes when necessary.</li><li> 
You prepare internal and external audits in collaboration with internal stakeholders and perform the action plans.</li></ul> 
Who are you?<ul><li> 
You have University Degree</li><li> 
You have Regulatory affairs and Quality experience in IVD/medical device industry</li><li> 
You have process knowledge and experience in ISO 9001 and ISO 13485 standards</li><li> 
You are experienced in conducting 2nd party audits &amp; 3rd party logistics processes</li><li> 
You are proactive and team worker.</li><li> 
You are Fluent in English</li></ul><div>
Who we are</div>
A healthier future drives us to innovate. Together, more than 100&rsquo;000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. 
Let&rsquo;s build a healthier future, together.
Roche is an Equal Opportunity Employer.</div>

Quality & Regulatory Specialist

Atrium Health

<div>Department:
85190 Greater Charlotte Research and Other Sponsored Programs - Academic Internal Medicine 
Status:
Full time 
Benefits Eligible:
Yes 
Hours Per Week:
40 
Schedule Details/Additional Information:
M-F, 8am-430pm
Pay Range
$30.15 - $45.25
This role is both grant and department funded.
Major Responsibilities:<ul><li>
Supports multiple complex clinical research studies, which may involve multi-centered, cooperative group studies, single site studies, intergroup studies, industry studies, and investigator-initiated studies.</li><li>
Plans, develops and prepares all required regulatory documents, including all initial, amendments and continuing reviews to the IRB, FDA, Office for Human Resource Protections (OHRP), and other regulatory bodies, including central offices of cooperative group studies, and sponsors where necessary. Supports submissions to ancillary committees.</li><li>
Interfaces with relevant review boards and sponsors to resolve questions or issues regarding regulatory submissions and ensure timely review and approval in compliance with local and external IRB SOPs and other regulatory agency requirements.</li><li>
Collaborates with the Research Business Services Office to assist with initial study submission, amendments and closeout.</li><li>
Collaborates with study team to ensure implementation of amendments, awareness of safety and protocol changes, and version control management.</li><li>
Acts as a liaison to investigators and research coordinators for reporting Adverse Events, noncompliance, and other FDA required reporting events.</li><li>
Maintains study level documentation for all studies, including those that are complex in nature. Ensure files are audit ready. Monitors compliance required documentation.</li><li>
Enters and maintains study information and regulatory approvals in electronic systems.</li><li>
Provides guidance and training to research staff to ensure compliance with highly complex, highly specialized regulations and guidance associated with clinical research studies and trials involving human subjects. Attends and participates in educational programs, meetings and assigned committees.</li><li>
Participates in the development and implementation of quality improvement and quality assurance activities. Other duties as assigned.</li></ul> 
Licensure, Registration, and/or Certification Required:<ul><li>
None Required.</li></ul> 
Education Required:<ul><li>
Bachelor's Degree (or equivalent knowledge) in Business or related field.</li><li>
Bachelor's Degree (or equivalent knowledge) in Health Care Administration or related field.</li></ul> 
Experience Required:<ul><li>
Typically requires 3 years of experience in research, clinical trials research and regulatory knowledge.</li><li>
Clinical Research Coordinator Experience a plus, ACRP (CCRC), SOCRA (CCRP), or Regulatory Affairs Certification (RAC) a plus. Workday, Concur, RedCap, Florence, and OnCore a plus.</li></ul> 
Knowledge, Skills &amp; Abilities Required:<ul><li>
Knowledge of FDA and DHHS regulations and ICH GCP guidelines, Human Subject Protection rules and regulations related to regulatory documents.</li><li>
Knowledge of policies, procedures and SOPs specifically related to regulatory documents.</li><li>
Knowledge of clinical trials and terminology required.</li><li>
Excellent verbal and written communication skills, organizational and time management skills with ability to work under pressure and meet deadlines. Ability to problem solve and work independently with a high degree to accuracy and attention to detail.</li><li>
Good understanding of computer software, Microsoft Office, Word, Excel, Adobe, and Teams</li><li>
Ability to travel between facilities as needed.</li></ul> 
Physical Requirements and Working Conditions:<ul><li>
Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders, and twist frequently during the work shift.</li><li>
Must have functional sight and hearing.</li><li>
Exposed to a normal office environment.</li><li>
Position may require travel. May be exposed to road and weather hazards.</li></ul> 
This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the incumbent. Incumbent may be required to perform other related duties.
Our Commitment to You:
Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more &ndash; so you can live fully at and away from work, including:
Compensation<ul><li>
Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training</li><li>
Premium pay such as shift, on call, and more based on a teammate's job</li><li>
Incentive pay for select positions</li><li>
Opportunity for annual increases based on performance</li></ul>
Benefits and more<ul><li>
Paid Time Off programs</li><li>
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability</li><li>
Flexible Spending Accounts for eligible health care and dependent care expenses</li><li>
Family benefits such as adoption assistance and paid parental leave</li><li>
Defined contribution retirement plans with employer match and other financial wellness programs</li><li>
Educational Assistance Program</li></ul> 
About Advocate Health
Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation&rsquo;s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.
Responsible for the preparation, review and submission of required regulatory documents to the Institutional Review Board (IRB), Food and Drug Administration (FDA), and other regulatory bodies, including central offices of cooperative group studies. Coordinates and interfaces between the regulatory bodies, industry representatives and the AARI team members. Responsible for supporting the clinical research activity and research staff through timely submission of regulatory documents for new and ongoing studies. Contributes to the development of Standard Operating Procedures (SOPs) and compliance policies in clinical research related to regulatory submissions. Promotes the ethical conduct of research.This position will be M-F, 8am-430pm</div>

Research Regulatory Specialist

Envista Holdings

<div>Operating Company: DEXIS 
Location: Istanbul,Istanbul,TR 
Date Posted: November 11, 2025 
Req Number: R5024578</div><div></div>
 <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&#286;LIK &Uuml;R&Uuml;NLER&#304; VE H&#304;ZMETLER&#304; L&#304;M&#304;TED &#350;&#304;RKET&#304;. 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 &quot;regulatory submission packages&quot; 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></ul><ul> <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></ul><ul> <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> <h2 class="jobSectionHeader">COMPETENCIES &ndash; Essential for the role</h2> 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

Dynex Technologies

<div>Description:

 About Dynex: Founded 70 years ago, DYNEX&reg; TECHNOLOGIES, Inc., is a leading designer and manufacturer of fully automated ELISA microplate workstations, laboratory instruments and associated consumables and accessories, seamlessly integrating advanced detection with fully automated sample handling. Our talented, multidisciplinary staff includes design and service engineers, applications scientists, marketing specialists and precision-manufacturing experts. All dedicated to perpetual innovation in product design and new application frontiers to deliver cutting-edge microplate processing systems that meet the rigorous demands of the most challenging applications and ultimately improve health outcomes and enhance life.
Job Summary: The Regulatory Affairs Specialist supports global regulatory submissions, registrations, labeling, and compliance activities related to Class I ELISA instruments, consumables, and service parts. This role is ideal for a regulatory professional who is comfortable operating in a fast-paced environment with evolving requirements and multiple jurisdictions.
Requirements:

 Essential Functions:<ul><li>
Assist in maintaining device registrations, listings, and international dossiers (FDA FURLS, IVDR documentation, etc.).</li><li>
Support updates to global product technical files, labeling, and IFU compliance (including translations management).</li><li>
Assist with regulatory impact assessments for engineering changes, ECNs/ECOs, software releases, and packaging revisions.</li><li>
Participate in regulatory renewals, annual listings and reporting, regulatory intelligence monitoring, and regulatory surveillance.</li><li>
Support preparation and/or compilation of regulatory submissions to competent authorities, distributors, or authorized representatives.</li><li>
Assist cross-functional partners (QA, Innovation, Operations, Service, Commercial) to ensure compliance with relevant regulations.</li><li>
Support Complaints/Vigilance/Post Market Surveillance documentation as needed (FDA 806/803 support, IMDRF codes, etc. if applicable).</li><li>
Maintain regulatory records in accordance with QMS procedures and document control requirements.</li><li>
Support inspection readiness and audit activities (FDA, NB, MDSAP &mdash; when applicable).</li><li>
Additional duties as assigned.</li></ul>
Supervisory Responsibilities: None.
Success Factors: To be able to work independently and to lead project teams. To stay up to date with the current regulatory changes. To be able to communicate effectively through both written media and verbally. Strong mediation and negotiation skills.
Minimum Qualifications/Education:
Required:<ul><li>
Bachelor&rsquo;s degree in a scientific, engineering, regulatory, or related field. Equivalent, extensive relevant experience may be considered in lieu of a degree.</li><li>
~2&ndash;3 years of regulatory affairs experience in a regulated industry (medical device preferred; biotech, pharma, combination products, or other FDA-regulated sector acceptable).</li><li>
Working knowledge of FDA medical device framework (21 CFR 820/QMSR, 21 CFR 807), EU IVDR and ISO 13485.</li><li>
Ability to understand, interpret, and apply regulatory requirements.</li><li>
Excellent communication, technical writing, and documentation skills.</li></ul>
Preferred:<ul><li>
Experience with Class I medical devices, IVDs, and/or laboratory instrumentation.</li><li>
Experience with international markets (EU IVDR, Health Canada, LATAM, APAC, MEA etc.).</li><li>
Familiarity with IFU translation and medical device labeling requirements.</li><li>
Regulatory Affairs Certification (RAC) or progress toward RAC.</li></ul>
Computer Skills: Computer literacy in Windows, Word, Excel, Power point and Visio.
Work Environment: On-site Office.
Physical Requirements: Must be able to meet National Institute for Occupational Safety &amp; Health (NIOSH) Standards.
NPM16</div>

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

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