Regulatory Affairs IVDR - Contractor (North Africa)
On-siteTunis, Tunis Governorate, Tunisia or Algiers, Algiers, Algeria
Job Summary
Support the development and execution of regulatory submission plans related to IVDR transition projects across the EU region. Collaborate with global Regulatory Affairs, Legal, Manufacturing, Supply Chain, Marketing, and Commercial teams to support regulatory initiatives and manage change control projects by coordinating with manufacturing sites. Support product registrations, amendments to existing approvals, and maintain regulatory databases while proactively escalating risks. Track submission status and regulatory milestones through defined KPIs and reporting platforms, and represent Regulatory Affairs at project meetings including IVDR and change control forums. Monitor regulatory developments, legislation, and industry standards within Algeria, Morocco, or Tunisia, conducting impact assessments and communicating changes to internal stakeholders.
Required Qualifications
- Minimum of 2 years' experience in Regulatory Affairs within the Medical Devices industry
- Experience supporting regulatory submissions, registrations, and change management activities
- 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
- 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
- Applicants must currently be based in one of the following countries: Algeria Morocco Tunisia
Desired Qualifications
- Ideally IVDs
- French language proficiency
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