Regulatory Affairs IVDR - Contractor (North Africa)
Location: Algeria, Morocco, or Tunisia (Remote/Hybrid as applicable)
Contract Type: Contractor
About the Opportunity
We are seeking an experienced Regulatory Affairs IVDR Contractor to support regulatory activities across the EMEA region, with a key focus on In Vitro Diagnostic Regulation (IVDR) transition projects, product registrations, regulatory compliance, and change control activities within the medical diagnostics industry.
This is an exciting opportunity for a regulatory professional with experience in medical devices, ideally IVDs, who thrives in a fast-paced, cross-functional environment and is passionate about ensuring regulatory compliance while supporting business objectives.
Key Responsibilities
- Support the development and execution of regulatory submission plans related to IVDR transition projects across the EU region.
- Collaborate with global Regulatory Affairs teams, Legal, Manufacturing, Supply Chain, Marketing, Commercial teams, and distributor markets to support regulatory initiatives.
- Manage and support applicable change control projects by coordinating with manufacturing sites and relevant stakeholders to obtain regulatory documentation and dossiers.
- Support product registrations and amendments to existing regulatory approvals and certificates.
- Maintain regulatory databases and proactively escalate risks where necessary.
- Track, monitor, and report submission status and regulatory milestones through defined KPIs and reporting platforms.
- Provide backup support for local Regulatory Affairs activities when required.
- Represent Regulatory Affairs at project meetings, including IVDR and change control forums.
- Monitor regulatory developments, legislation, and industry standards within supported markets.
- Conduct regulatory impact assessments and communicate relevant changes to internal stakeholders.
- Support strategic Quality and Regulatory Affairs objectives.
- Perform additional regulatory and compliance-related duties as required.
Minimum Requirements
Education & Experience
- Minimum of 2 years' experience in Regulatory Affairs within the Medical Devices industry, preferably in In Vitro Diagnostics (IVDs).
- Demonstrated knowledge of the medical diagnostics industry and regulatory environments within supported regions.
- Experience supporting regulatory submissions, registrations, and change management activities.
Skills & Competencies
- Strong project management capabilities.
- Ability to work effectively within cross-functional and multicultural teams.
- Working knowledge of local Ministry of Health regulations, regulatory requirements, industry standards, and guidance documents.
- Excellent verbal and written communication skills in English.
- French language proficiency will be advantageous.
- Strong attention to detail and organizational skills.
- Excellent interpersonal and stakeholder management abilities.
- High levels of professionalism, integrity, and diplomacy.
- Ability to manage confidential information with discretion.
- Strong analytical and problem-solving skills.
Preferred Candidate Location
Applicants must currently be based in one of the following countries:
What We're Looking For
The successful candidate will be a proactive regulatory professional who can work independently, manage multiple priorities, and collaborate effectively with stakeholders across various functions and geographies.
Interested candidates are invited to submit their CV highlighting their relevant Regulatory Affairs and IVDR experience.
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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.