Regulatory Affairs Specialist
7 days ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Compunnel Inc. in the biotechnology industry.
Job Summary:
As a Regulatory Affairs Specialist, you will be responsible for coordinating post-market regulatory programs and ensuring compliance with global regulations.
Key Responsibilities:
- Support global registration efforts across various regions, including the EU, Canada, Brazil, Latin America, and Asia Pacific.
- Interpret and apply federal, state, and international regulations to products and processes.
- Liaise with regulatory bodies and resolve compliance issues.
- Prepare and submit regulatory reports, licenses, and listings.
- Manage regulatory clearances, device listings, and import/export requirements.
- Maintain regulatory intelligence and ensure ongoing compliance.
Requirements:
- 3-5 years of experience in Diagnostic Regulatory Affairs, with knowledge of IVD/IVDR.
- Experience in global registrations across various regions.
- Bachelor's degree with 5 years of relevant experience, or equivalent advanced degree.
- Background in medical devices, pharmaceuticals, or in-vitro diagnostics preferred.
- Strong communication and prioritization skills.
- Experience with LEAN principles and risk management (FMEA/HHA) is a plus.
- RAC certification preferred.
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