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regulatory affairs specialist

Masimo

<div>Duties &amp; Responsibilities:
<ul><li>Process and maintain international filings/registrations in the assigned countries within the META Region.
</li><li>Generate and maintain product and process compliance checklists for the assigned countries.
</li><li>Maintain up-to-date knowledge on applicable regulatory requirements in the assigned countries.
</li><li>Provide counsel, training, and interpretation of applicable META Region regulatory requirements to company personnel.
</li><li>Liaise with in-country representatives on all matters relative to product and process regulatory requirements.
</li><li>Support operations, marketing, and sales with global market approvals for product shipment.
</li><li>Prepare and maintain other regulatory documentation, as needed in the assigned countries.
</li><li>Contribute to the implementation of regulatory best practices and efficient processes for regulatory information management.
</li><li>Generate/update quality system procedures owned by Regulatory Affairs, as required.
</li><li>Participate in relevant projects as regulatory subject matter expert.
</li><li>Perform other duties or special projects, as assigned.
</li><li>Collaborate with QA to drive Quality compliance in the region 
</li></ul>Minimum Qualifications:
<ul><li>Minimum 3 years of experience in international medical device Regulatory Affairs.
</li><li>Experience with the current Middle East regulations
</li><li>Excellent verbal and written communication skills in English.
</li><li>Experience working remotely with in-country representatives and with USA-based headquarters.
</li><li>Excellent prioritizing, organizational and interpersonal skills.
</li><li>Willingness to accommodate a flexible working schedule across time zones that may involve evening and weekend working hours depending on project requirements.
</li><li>Ability to work in a fast-paced environment, with multiple tasks/projects.
</li><li>A detailed-oriented individual with a &ldquo;can do&rdquo; attitude and ability to work in a team environment as well as individually with minimal supervision. 
</li></ul>Preferred Qualifications: 
<ul><li>3-7 years of related work experience.
</li><li>Experience in patient monitoring systems, hospital-based equipment, software or electronic devices.
</li><li>Good knowledge of the META Region regulations on electro-medical devices.
</li><li>Experience interacting with regulatory bodies.
</li><li>Proficient in document management systems, such as Oracle Agile PLM.
</li><li>Prior experience working within countries in Middle East &amp; Africa.
</li><li>Prior experience working in international organizations. 
</li></ul>Education: 
BA/BS Degree, or equivalent combination of education and experience is required. Preferred degrees in sciences, engineering, or biomedical engineering. 
Are you looking for uncommon opportunities with an extraordinary company? We are looking for people who can, do and will make a difference. Are you interested to hear more about this position?
Please send your full application.
To learn more about us, please visit: www.masimo.com</div>

Regulatory Affairs Specialist I

Johnson & Johnson

<div>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson &amp; Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Product Submissions and Registration
Job Category:
Professional
All Job Posting Locations:
Riyadh, Saudi Arabia
Job Description:
About MedTech
Fueled by innovation at the intersection of biology and technology, we&rsquo;re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are searching for the best talent for Regulatory Affairs Specialist.
Purpose:
The main task of a Regulatory Affairs specialist in Johnson &amp; Johnson is Launching of Medical Device Products in Saudi Arabia Market in compliance with the Regulatory registration &amp; importation guidance.
You will be responsible for:<ul><li>
Preparing, compiling and submission of registration/ re-registration products files in addition to variation submission on time directly in Saudi Arabia or through J&amp;J distributors when applicable</li><li>
SFDA meetings.</li><li>
Clearance support to distributers.</li><li>
Updating the regulatory tracking systems</li><li>
Having the renewed certificates &amp; re-registration licenses of expired ones on time.</li><li>
Responding to Change Impact Assessments before due dates.</li><li>
Doing Copy Review process for promotional materials on time upon request.</li><li>
Lift all regulatory restrictions for products that can be shipped to Saudi Arabia</li><li>
Tender support to commercial teams &amp; distributers</li></ul>
Qualifications / Requirements:<ul><li>
Education: Bachelor&rsquo;s (B.Sc.) Degree of Biomedical engineering or Sciences</li><li>
Experience; min. 2 years</li><li>
Language: English - Arabic 
</li></ul>Key Competencies:<ul><li>
Time Management</li><li>
Presentation &amp; Communication Skills</li><li>
Involvement in Regional Projects.</li></ul>
Required Skills:
Preferred Skills:
Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Execution Focus, Market Research, Package and Labeling Regulations, Process Oriented, Product Licensing, Product Packaging Design, Project Management, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Safety-Oriented</div>

Regulatory Affairs Specialist | Johnson & Johnson MedTech | Riyadh - KSA

Imdad

<div>Regulatory Affairs Senior Specialist acts as the liaison between the company and regulatory authorities (SFDA) to ensure that imported products are manufactured and distributed in compliance with appropriate governmental legislation.
Job Responsibilities
I. Regulatory Affairs:<ul><li>
Act as one of the main points of contact for SFDA and be responsible for Imdad&rsquo;s products.</li><li>
Report the status of the products and related tasks on a monthly basis.</li><li>
Ensure that the equipment is in compliance with SFDA regulations.</li><li>
Follow up with logistics for the importation of Imdad&rsquo;s products including Equipment, Accessories and cosmetics.</li><li>
Obtain Faseh &amp; Nnjzha approval for logistics to ensure compliant importation of products.</li><li>
Ensure approval of product registration applications for equipment, cosmetics, and accessories in KSA.</li><li>
Ensure the update of registrations in accordance with relevant legislation, regulations, and guidelines.</li><li>
Prepare complete registration dossiers for all products, including reviewing and verifying their compliance with SFDA requirements and regulations.</li><li>
Coordinate with suppliers regarding equipment specifications and documentation.</li><li>
Review and validate all documents before submission to SFDA.
</li><li>Track and ensure that applicable fees are paid on time and all licenses are renewed in a timely manner.</li><li>
Support other internal departments with regulatory requests and complaints.
</li><li>Monitor updates to SFDA regulations, guidelines, and circulars, assess their impact on company products, and ensure timely implementation of required changes.</li></ul>
II. Quality Assurance:<ul><li>
Ensure that the QMS processes are established, implemented, and maintained.</li><li>
Report to the direct manager on how well or poorly the QMS is performing.</li><li>
Regularly review the QMS objectives.</li><li>
Maintain appropriate records.</li><li>
Ensure that all Good Distribution and Storage Practices are applied.</li></ul> 

Requirements 
 
Minimum Qualifications<ul><li>
Bachelor&rsquo;s degree in biomedical engineering or any related Medical Scientific Field
</li><li>Minimum 2 years of experience in Regulatory Affairs</li></ul> 
Required Skills<ul><li>
Excellent communication skills (oral &amp; written), and ability to work well in a team.</li><li>
Time Management skills.</li><li>
Good computer skills (MS. Office, Excel &amp; Outlook)</li><li>
Good knowledge on SFDA Platforms ( Ghad, NnJzha, Faseh ).</li><li>
Excellent organization skills.</li><li>
Excellent Arabic and English skills (Written &amp; spoken).</li></ul></div>

Regulatory Affairs & Quality Assurance Senior Specialist - Riyadh

Procter & Gamble

<div>
 
 Job Location
 
 
 
 Riyadh
 
 
 
 Job Description
 
 
 
 
 Overview of the job
 
 
 
 In this role, you will contribute to advancing P&amp;G Personal Healthcare&rsquo;s growth in the Kingdom of Saudi Arabia by leading regulatory strategies and supporting policy engagement to enable timely product approvals and sustainable market access. You will develop and execute Regulatory Affairs strategies across the product lifecycle from regulatory pathway assessment and submissions to approvals and compliance ensuring alignment with local regulatory requirements.
 
 
 In parallel, you will support Policy Affairs efforts through engagement with regulatory authorities, government bodies, and industry associations to advocate for science-based policies and contribute to an enabling regulatory environment for innovation and patient access.
 
 
 The role requires strong regulatory expertise, strategic thinking, and effective stakeholder management to navigate complex regulatory landscapes, ensure compliance, and support improved access for current and future P&amp;G PHC products in the Saudi market.
 
 
 
 Your team
 
 
 
 This role reports to Director of Research &amp; Development, Regulatory Affairs Middle East &amp; Africa &amp; will look after Saudi Arabia market
 
 
 
 How Success Looks Like
 
 
 
 <ul>
 <li>
 You understand regulatory requirements deeply and apply them effectively to ensure compliance for Saudi Arabia market.
 </li>
 <li>
 You develop and implement regulatory strategies that streamline product submissions and registrations, resulting in timely market access.
 </li>
 <li>
 You build and maintain strong relationships with regulatory authorities, leveraging these connections to partnership for faster route to market.
 </li>
 <li>
 You lead and execute training programs for the regulatory team and other departments, ensuring they are informed and up to date on regulatory requirements and best practices.
 </li>
 <li>
 You provide strategic guidance and support to cross-functional teams, ensuring regulatory considerations are integrated into product development and business processes.
 </li>
 <li>
 Designs or sources health economic projects to optimize messaging and favourable perception/adoption of products/technologies/procedures as required.
 </li>
 <li>
 You proactively identify potential regulatory risks and develop strategies to ensure continuous compliance and business continuity.
 </li>
 <li>
 You effectively manage and mentor teams, fostering a culture of excellence, collaboration, and professional growth within the regulatory affairs function.
 
 
 </li>
 </ul>
 
 Responsibilities Of The Role
 
 
 
 <ul>
 <li>
 Lead and coordinate day-to-day Regulatory Affairs activities for assigned products and initiatives, ensuring alignment with regional and global regulatory strategies.
 </li>
 <li>
 Monitor and assess the evolving regulatory landscape across Saudi Arabia, providing strategic insights on regulatory changes and their impact on business operations and product registrations.
 </li>
 <li>
 Ensure compliance with global, regional, and local regulatory requirements by implementing and maintaining appropriate processes, policies, SOPs, and working instructions.
 </li>
 <li>
 Manage the preparation, compilation, and submission of regulatory dossiers, including responses to health authority queries and regulatory correspondence in accordance with applicable guidelines and country-specific requirements.
 </li>
 <li>
 Collaborate cross-functionally with R&amp;D, Commercial, Quality, Supply Chain, and Legal teams to support regulatory strategies that enable efficient product approvals and lifecycle management.
 </li>
 <li>
 Build and maintain effective relationships with regulatory authorities and relevant external stakeholders to support transparent communication and facilitate regulatory processes.
 </li>
 <li>
 Support the development and execution of Public Policy and advocacy initiatives by engaging with industry associations, government entities, and regulatory bodies to promote science-based, predictable, and innovation-friendly regulatory frameworks.
 </li>
 <li>
 Contribute to shaping policy positions and industry proposals that support improved regulatory pathways, market access, and patient access to healthcare products.
 
 
 </li>
 </ul>
 Core Regulatory &amp; Policy Practices:
 
 
 <ul>
 <li>
 To prepare &amp; submit registration dossiers and to achieve registration for the specific product portfolio, within agreed timelines.
 </li>
 <li>
 To update and maintain dossiers post registration, to ensure compliance with corporate and health authority legal requirements. This will include the submission of variation documents.
 </li>
 <li>
 To ensure the renewal of registration of products by defining the accurate timelines.
 </li>
 <li>
 To ensure maintenance and update of regulatory files and records including appropriate archiving of all relevant documentation in appropriate system in line with applicable internal company standards
 </li>
 <li>
 To review and ensure the conformity of the product artworks, promotional material and tools with the marketing code and legal requirements.
 </li>
 <li>
 To Liaise with health authorities, distributors, regulatory authorities, and trade associations to achieve and maintain registrations.
 </li>
 <li>
 To develop relationships with regulatory bodies to represent the interests of the organization, gain relevant information and help shape change.
 </li>
 <li>
 Leads, monitors, assesses, and communicates risks on key projects, providing regular updates to Stakeholders and Senior Management
 </li>
 <li>
 Monitors and progress of applications against set timelines, acting where necessary, to minimize delays and anticipate difficulties/challenges.
 </li>
 <li>
 Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.
 </li>
 <li>
 Affect legislative and executive public policy outcomes by educating, persuading, and negotiating with policy makers; creating political allies; building coalitions; and utilizing the P&amp;G Government Relations resources, policies, and expertise to achieve the company&rsquo;s political and business objectives.
 </li>
 <li>
 Monitor legislative developments and identify emerging issues to the company, and in coordination with management and global government relations and public policy function; develop company positions and priorities on public policy issues which impact P&amp;G&rsquo;s business and position.
 
 
 </li>
 </ul>
 
 Role Requirements
 
 
 
 Qualifications &amp; technical skills
 
 
 <ul>
 <li>
 Saudi Licensed Pharmacist from Saudi commission for health specialities
 </li>
 <li>
 Years of Experience: 5 Years or more in Pharmaceutical/ Personal Healthcare Regulatory Experience
 </li>
 <li>
 Language: English and Arabic Fluency.
 </li>
 <li>
 Location: Riyadh KSA
 
 
 </li>
 </ul>
 Soft skills
 
 
 <ul>
 <li>
 Proven ability to effectively negotiate with SFDA on technical and policy matters to drive optimal outcomes.
 </li>
 <li>
 Experience from a multi-national or regional company is required.
 </li>
 <li>
 Experience in Pharma &amp; Consumer Personal Healthcare products
 </li>
 <li>
 Excellent Oral &amp; written communication skills, interpersonal, and influencing skills.
 </li>
 <li>
 Effective communications with different audiences.
 </li>
 <li>
 Negotiations, Coalition, and effective lobbying skills.
 </li>
 <li>
 Team activity, collaborative individual and must have the ability to establish relationships across departments to handle and deliver departmental result
 
 
 </li>
 </ul>
 
 About Us
 
 
 
 We produce globally recognized brands and we grow the best business leaders in the industry. With a portfolio of trusted brands as diverse as ours, it is paramount our leaders are able to lead with courage the vast array of brands, categories and functions. We serve consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always&reg;, Ariel&reg;, Gillette&reg;, Head &amp; Shoulders&reg;, Herbal Essences&reg;, Oral-B&reg;, Pampers&reg;, Pantene&reg;, Tampax&reg; and more. Our community includes operations in approximately 70 countries worldwide.
 
 
 Visit http://www.pg.com to know more.
 
 
 We are an equal opportunity employer and value diversity at our company. We do not discriminate against individuals on the basis of race, color, gender, age, national origin, religion, sexual orientation, gender identity or expression, marital status, citizenship, disability, HIV/AIDS status, or any other legally protected factor.
 
 
 
 Job Qualifications
 
 
 
 <ul>
 <li>
 Saudi Licensed Pharmacist from Saudi commission for health specialities
 </li>
 <li>
 Years of Experience: 5 Years or more in Pharmaceutical/ Personal Healthcare Regulatory Experience
 </li>
 <li>
 Language: English and Arabic Fluency.
 </li>
 <li>
 Location: Riyadh KSA
 
 
 </li>
 </ul>
 
 Job Schedule
 
 
 
 Full time
 
 
 
 Job Number
 
 
 
 R000147983
 
 
 
 Job Segmentation
 
 
 
 Experienced Professionals
</div>

Senior Manager - Regulatory & Policy Affairs

<div>Job Location
Riyadh
Job Description
Overview of the job
In this role, you will contribute to advancing P&amp;G Personal Healthcare&rsquo;s growth in the Kingdom of Saudi Arabia by leading regulatory strategies and supporting policy engagement to enable timely product approvals and sustainable market access. You will develop and execute Regulatory Affairs strategies across the product lifecycle from regulatory pathway assessment and submissions to approvals and compliance ensuring alignment with local regulatory requirements.
In parallel, you will support Policy Affairs efforts through engagement with regulatory authorities, government bodies, and industry associations to advocate for science-based policies and contribute to an enabling regulatory environment for innovation and patient access.
The role requires strong regulatory expertise, strategic thinking, and effective stakeholder management to navigate complex regulatory landscapes, ensure compliance, and support improved access for current and future P&amp;G PHC products in the Saudi market.
Your team
This role reports to Director of Research &amp; Development, Regulatory Affairs Middle East &amp; Africa &amp; will look after Saudi Arabia market
How Success Looks Like<ul><li>
You understand regulatory requirements deeply and apply them effectively to ensure compliance for Saudi Arabia market.</li><li>
You develop and implement regulatory strategies that streamline product submissions and registrations, resulting in timely market access.</li><li>
You build and maintain strong relationships with regulatory authorities, leveraging these connections to partnership for faster route to market.</li><li>
You lead and execute training programs for the regulatory team and other departments, ensuring they are informed and up to date on regulatory requirements and best practices.</li><li>
You provide strategic guidance and support to cross-functional teams, ensuring regulatory considerations are integrated into product development and business processes.</li><li>
Designs or sources health economic projects to optimize messaging and favourable perception/adoption of products/technologies/procedures as required.</li><li>
You proactively identify potential regulatory risks and develop strategies to ensure continuous compliance and business continuity.</li><li>
You effectively manage and mentor teams, fostering a culture of excellence, collaboration, and professional growth within the regulatory affairs function.</li></ul>
Responsibilities of the role<ul><li>
Lead and coordinate day-to-day Regulatory Affairs activities for assigned products and initiatives, ensuring alignment with regional and global regulatory strategies.</li><li>
Monitor and assess the evolving regulatory landscape across Saudi Arabia, providing strategic insights on regulatory changes and their impact on business operations and product registrations.</li><li>
Ensure compliance with global, regional, and local regulatory requirements by implementing and maintaining appropriate processes, policies, SOPs, and working instructions.</li><li>
Manage the preparation, compilation, and submission of regulatory dossiers, including responses to health authority queries and regulatory correspondence in accordance with applicable guidelines and country-specific requirements.</li><li>
Collaborate cross-functionally with R&amp;D, Commercial, Quality, Supply Chain, and Legal teams to support regulatory strategies that enable efficient product approvals and lifecycle management.</li><li>
Build and maintain effective relationships with regulatory authorities and relevant external stakeholders to support transparent communication and facilitate regulatory processes.</li><li>
Support the development and execution of Public Policy and advocacy initiatives by engaging with industry associations, government entities, and regulatory bodies to promote science-based, predictable, and innovation-friendly regulatory frameworks.</li><li>
Contribute to shaping policy positions and industry proposals that support improved regulatory pathways, market access, and patient access to healthcare products.</li></ul>
Core Regulatory &amp; Policy Practices:<ul><li>
To prepare &amp; submit registration dossiers and to achieve registration for the specific product portfolio, within agreed timelines.</li><li>
To update and maintain dossiers post registration, to ensure compliance with corporate and health authority legal requirements. This will include the submission of variation documents.</li><li>
To ensure the renewal of registration of products by defining the accurate timelines.</li><li>
To ensure maintenance and update of regulatory files and records including appropriate archiving of all relevant documentation in appropriate system in line with applicable internal company standards</li><li>
To review and ensure the conformity of the product artworks, promotional material and tools with the marketing code and legal requirements.</li><li>
To Liaise with health authorities, distributors, regulatory authorities, and trade associations to achieve and maintain registrations.</li><li>
To develop relationships with regulatory bodies to represent the interests of the organization, gain relevant information and help shape change.</li><li>
Leads, monitors, assesses, and communicates risks on key projects, providing regular updates to Stakeholders and Senior Management</li><li>
Monitors and progress of applications against set timelines, acting where necessary, to minimize delays and anticipate difficulties/challenges.</li><li>
Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.</li><li>
Affect legislative and executive public policy outcomes by educating, persuading, and negotiating with policy makers; creating political allies; building coalitions; and utilizing the P&amp;G Government Relations resources, policies, and expertise to achieve the company&rsquo;s political and business objectives.</li><li>
Monitor legislative developments and identify emerging issues to the company, and in coordination with management and global government relations and public policy function; develop company positions and priorities on public policy issues which impact P&amp;G&rsquo;s business and position.</li></ul>
Role Requirements
Qualifications &amp; technical skills<ul><li>
Saudi Licensed Pharmacist from Saudi commission for health specialities</li><li>
Years of Experience: 5 Years or more in Pharmaceutical/ Personal Healthcare Regulatory Experience</li><li>
Language: English and Arabic Fluency.</li><li>
Location: Riyadh KSA</li></ul>
Soft skills<ul><li>
Proven ability to effectively negotiate with SFDA on technical and policy matters to drive optimal outcomes.</li><li>
Experience from a multi-national or regional company is required.</li><li>
Experience in Pharma &amp; Consumer Personal Healthcare products</li><li>
Excellent Oral &amp; written communication skills, interpersonal, and influencing skills.</li><li>
Effective communications with different audiences.</li><li>
Negotiations, Coalition, and effective lobbying skills.</li><li>
Team activity, collaborative individual and must have the ability to establish relationships across departments to handle and deliver departmental result</li></ul>
About us
We produce globally recognized brands and we grow the best business leaders in the industry. With a portfolio of trusted brands as diverse as ours, it is paramount our leaders are able to lead with courage the vast array of brands, categories and functions. We serve consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always&reg;, Ariel&reg;, Gillette&reg;, Head &amp; Shoulders&reg;, Herbal Essences&reg;, Oral-B&reg;, Pampers&reg;, Pantene&reg;, Tampax&reg; and more. Our community includes operations in approximately 70 countries worldwide.
Visit http://www.pg.com to know more.
We are an equal opportunity employer and value diversity at our company. We do not discriminate against individuals on the basis of race, color, gender, age, national origin, religion, sexual orientation, gender identity or expression, marital status, citizenship, disability, HIV/AIDS status, or any other legally protected factor.
Job Qualifications<ul><li>
Saudi Licensed Pharmacist from Saudi commission for health specialities</li><li>
Years of Experience: 5 Years or more in Pharmaceutical/ Personal Healthcare Regulatory Experience</li><li>
Language: English and Arabic Fluency.</li><li>
Location: Riyadh KSA</li></ul>
Job Schedule
Full time
Job Number
R000147983
Job Segmentation
Experienced Professionals</div>

Teleflex

<div>
 
 
 JOB PURPOSE:
 
 
 
 Support the regulatory activities which lead to and maintain regulatory compliance and approval for Teleflex Medical products in the EMEA region.
 
 
 
 
 
 
 PRINCIPAL RESPONSIBILITIES:
 
 
 
 Key responsibilities will include (but are not limited to) the following:
 
 
 
 
 
 &bull; Coordination and management of regulatory and product registration activities for the EMEA region
 
 
 &bull; Responsible for providing RA input for projects in a timely manner.
 
 
 &bull; Preparation of internal reports and change control documents, and the review of documents for potential impact on global regulatory submissions.
 
 
 &bull; Preparation of product registration files for submission to global regulatory bodies/agencies to obtain product approvals and maintain regulatory compliance with international regulatory requirements.
 
 
 &bull; Participation in project work such as new product introductions, changes to existing products and processes, and other regulatory/company projects as required.
 
 
 &bull; Preparation of information to support Product Tender Applications in the international markets and to support customer services with the shipment of products.
 
 
 &bull; Support internal and external audits.
 
 
 &bull; Support maintenance of product registration database
 
 
 &bull; Review and evaluate technical and scientific data and reports and incorporate them into documents for submission to regulatory agencies.
 
 
 &bull; Support regulatory impact assessments for EMEA region.
 
 
 &bull; Ensure local site regulatory procedures are aligned with global procedures.
 
 
 &bull; Pursue relevant information pertaining to new developments in regulatory affairs.
 
 
 &bull; Provide support on other activities as required by immediate supervisor.
 
 
 &bull; Adhere to and ensure the compliance of Teleflex&rsquo;s Code of Ethics, all company policies, rules, procedures, and housekeeping standards.
 
 
 
 
 
 
 EDUCATION / EXPERIENCE REQUIREMENTS:
 
 
 
 &bull; Degree in a relevant Science or Engineering discipline required.
 
 
 &bull; 2-3 years medical device industry experience within quality or regulatory desired.
 
 
 &bull; Technical writing expertise.
 
 
 &bull; Basic knowledge and understanding of EU and international medical device regulations, standards and guidance documents.
 
 
 &bull; Project Management skills and experience.
 
 
 
 
 
 
 
 
 
 OTHER SKILLS / REQUIREMENTS:
 
 
 
 &bull; Self-driven and ability to work independently and/ or as a team player.
 
 
 &bull; Approachable and enthusiastic. Flexible and adaptable.
 
 
 &bull; Able to work on own initiative and as a team player.
 
 
 &bull; Good organisational skills with cultural awareness and sensitivity.
 
 
 &bull; Good judgment and problem-solving ability &amp; capable of understanding the impact of decision making on both Teleflex and customers.
 
 
 &bull; Excellent Communication skills both written and verbal.
 
 
 &bull; Interface with various departments as applicable for the project to ensure all regulatory deliverables are achieved.
 
 
 &bull; Communicate concerns effectively to the RA Manager and project teams to ensure that they are addressed.
 
 
 &bull; Participate in project meetings to provide regulatory inputs during the planning, execution and closure of the projects.
 
 
 &bull; Pharmaceutical and/or Drug/ Device Combination device experience and Clinical expertise an advantage.
 
 
 
 
 
 
 Key Relationships / Interfaces:
 
 
 
 &bull; Global QARA
 
 
 
 
 
 
 Behaviours &amp; Values:
 
 
 
 
 
 
 
 TRAVEL REQUIRED:
 
 Approx 10% travel required
 
 
 
 
 
 Applicants must have the legal right to work in the Kingdom of Saudi Arabia at the time of application. This includes holding valid residency and work authorisation documentation, or being a Saudi national eligible for employment under applicable law.
 
 
 In accordance with the Kingdom's Nitaqat programme and Ministry of Human Resources and Social Development requirements, Teleflex [is committed to the employment and professional development of Saudi nationals. Priority consideration will be given to qualified Saudi national candidates as part of our commitment to supporting the Kingdom's nationalisation objectives. Teleflex] actively encourages applications from Saudi nationals for this position.
 
 
 
</div>

Senior Regulatory Affairs Associate

VITROLIFE

<div>At the Vitrolife Group, we work every day to unlock the full potential of science and technology to reduce the barriers towards building a family. Together we help our customers and their patients to fulfill the dream of having a baby. 
Make Quality Matter &mdash; Where It Impacts Lives.
We are looking for a Quality Assurance Specialist to strengthen and advance our local quality operations in Riyadh. This role sits at the intersection of regulatory excellence, operational quality, and continuous improvement, ensuring that our laboratory services meet the highest international and local standards.
You will play a key role in driving compliance, enabling safe and effective services, and embedding a proactive quality culture &mdash; working closely with both local teams and regional quality leadership.<h4 class="jobSectionHeader"> 
Your Impact</h4>
As a Quality Assurance Specialist, you will:<h6 class="jobSectionHeader">
Drive Quality Operations &amp; Compliance</h6><ul><li>
Oversee day-to-day quality activities and ensure adherence to local and regional requirements</li><li>
Maintain accurate quality records and actively participate in quality management forums</li><li>
Ensure compliance with MOH, SFDA, CBAHI, and other applicable regulations</li></ul><h6 class="jobSectionHeader">
Strengthen the Quality Management System (QMS)</h6><ul><li>
Manage document control processes to ensure procedures are current, compliant, and accessible</li><li>
Support implementation and updates of local and global procedures</li><li>
Contribute to continuous improvement of QMS processes</li></ul><h6 class="jobSectionHeader">
Lead Audits, Risk &amp; Continuous Improvement</h6><ul><li>
Plan and conduct internal audits; manage findings and CAPA implementation</li><li>
Support external audits and regulatory inspections</li><li>
Lead local risk assessments and foster a proactive risk management culture</li></ul><h6 class="jobSectionHeader">
Manage Deviations, CAPA &amp; Performance</h6><ul><li>
Investigate deviations and ensure effective CAPA closure</li><li>
Monitor KPIs, incidents, and nonconformities</li><li>
Identify trends and escalate critical insights to Regional Quality Management</li></ul><h6 class="jobSectionHeader">
Enable Regulatory &amp; Operational Excellence</h6><ul><li>
Monitor regulatory changes and ensure timely implementation</li><li>
Support licensing, certifications, and renewals</li><li>
Ensure quality alignment in new or modified services</li></ul><h6 class="jobSectionHeader">
Collaborate &amp; Build Capability</h6><ul><li>
Train and support staff on quality and regulatory requirements</li><li>
Evaluate the external critical suppliers/service provider and referral laboratories to ensure compliance</li><li>
Contribute to regional and global quality initiatives and harmonization efforts</li></ul><h4 class="jobSectionHeader">
Who You Are</h4>
You are a structured, analytical, and proactive quality professional who thrives in regulated environments and enjoys collaborating across teams.<h4 class="jobSectionHeader">
Qualifications</h4><ul><li>
Bachelor&rsquo;s degree in Laboratory Sciences, Biomedical Sciences, or related field</li><li>
SCFHS license (preferred)</li><li>
Certification in Quality Assurance or Regulatory Affairs is a plus</li></ul><h4 class="jobSectionHeader">
Experience</h4><ul><li>
3&ndash;4 years in a similar QA/regulatory role</li><li>
Experience within laboratory or medical environment</li><li>
Strong knowledge of:<ul><li>
MOH and SFDA regulations (required)</li><li>
CBAHI standards (required)</li><li>
ISO 15189 and CAP accreditation (preferred)</li></ul></li></ul><h4 class="jobSectionHeader">
Skills</h4><ul><li>
Strong understanding of QMS, audits, and documentation</li><li>
Experience with QMS/LIS systems</li><li>
Excellent problem-solving and organizational skills</li><li>
Strong communication and collaboration abilities</li><li>
Fluent in Arabic and English (written and spoken)</li></ul><h4 class="jobSectionHeader">
What You Bring Beyond the Basics</h4><ul><li>
A proactive mindset &mdash; you don&rsquo;t wait for issues, you prevent them</li><li>
The ability to translate regulations into practical, working processes</li><li>
Confidence to challenge, improve, and influence</li><li>
A strong sense of ownership and accountability</li></ul><h4 class="jobSectionHeader">
Why Join Us</h4><ul><li>
Be part of an organization where quality is central to patient impact</li><li>
Work in a collaborative regional and global environment</li><li>
Contribute to high-standard laboratory services and continuous improvement</li><li>
Grow within a culture that values expertise, structure, and innovation</li></ul><h6 class="jobSectionHeader">
Additional Information</h6><ul><li>
Preference will be given to Saudi Nationals</li></ul>
Vitrolife Group is a global provider of medical devices and genetic services. Based on science and advanced research capabilities, we develop services and products for personalized genetic information and medical device products. We support our customers by improving their clinical practice for the patient's outcome of fertility treatment.
We are currently approximately 1 100 colleagues worldwide, with headquarters in Gothenburg, Sweden. Vitrolife Group's products and services are available in more than 110 countries through our own presence in 30 countries and a network of distributors. Vitrolife Group is a sustainable market leader and aims to be the preferred partner for IVF-clinics by providing superior products and services with the vision of fulfilling the dream of having a baby. The Vitrolife share is listed on Nasdaq Stockholm.</div>

Quality Assurance Specialist

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