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Regulatory Affairs and Compliance Specialist
EssityRegulatory Affairs & Compliance Specialist managing medical device regulatory documentation in Turkey. Collaborating across teams to ensure compliance and support market authorization.
About the role
Key responsibilities & impact- Compile and collate documentation and technical product files necessary for the market authorization, registration and reimbursement of the assigned product assortment (Medical Device and Cosmetics).
- Ensure that all documents and processes are in accordance with internal regulatory and quality procedures as well as applicable national laws and regulations.
- Maintain product records and regulatory information in applicable Ministry of Health systems, including UTS and other regulatory platforms.
- Support compliance activities associated with Economic Operator obligations, product traceability requirements and post-market regulatory obligations.
- Establish and maintain a project chart and an authorization overview for registration and reimbursement submissions.
- Monitor changes in healthcare, medical device and reimbursement regulations and communicate impacts to relevant stakeholders.
- Provide input to support processes related to regulatory, quality, reimbursement and compliance.
- Assist in Document Control & Change Control activities.
- Support the commercial team in collecting and preparing documentation required for tender submissions.
- Support and facilitate healthcare compliance reviews, including Independent Decision Making Process (IDMP).
Requirements
What you’ll need- A University graduate, who holds a degree in biology, molecular biology & genetics, chemistry, chemical engineering, medicine, pharmacy, health sciences or biomedical engineering.
- Knowledgeable in healthcare compliance, medical device regulations and regulatory intelligence, with project management and stakeholder management skills.
- Digital-savvy, with proficiency in Microsoft 365, document management systems and local regulatory databases.
- A professional with 3-5 years of experience in the medical industry in regulatory affairs and market access, quality and/or a healthcare compliance function at a country level.
- Experience with UTS, TITCK regulations and reimbursement processes is an advantage.
- Communication expert with excellent oral / written communications skills in Turkish and English.
Benefits
Comp & perks- Collaborative and Inclusive Culture
- Empowering & Engaged Leaders
- Working with Powerful Purpose & Sustainable Impact
- Learning and Growing in your Career
- Supporting Well-being & Sustainable Working Life
- Life-changing Innovations
- Competitive Total rewards
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Regulatory IntelligenceDocument ControlChange ControlMarket AuthorizationReimbursement ProcessesProduct TraceabilityQuality ProceduresTechnical DocumentationHealthcare RegulationsDigital Proficiency
Soft Skills
Communication SkillsInterpersonal SkillsCollaboration