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Our mid-sized medical client is adding a Sr. Regulatory Affairs Specialist to their team! The Sr. Regulatory Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed. The Regulatory Affairs Specialist will perform regulatory submission/approval activities for specific products and ensures compliance with required regulations and established corporate standards.
Your role with the company:
- Prepare documentation for international regulatory registration
- Prepare technical documentation compliant to MDD and EU MDR
- Define worldwide regulatory requirements necessary for regulatory approval of assigned products
- Participate on cross functional teams as regulatory lead
- Complete worldwide regulatory assessments and change orders
- Execute product submission strategies as directed
- Maintain all regulatory documentation to ensure availability for external audits and preparation of submission packages
- Review protocols and reports for scientific validity and compliance to regulatory standards and provide scientific judgement to guide cross functional teams.
- Author submissions, research requirements, set priorities and maintain project schedulesProvide guidance and oversight to team members related to regulatory compliance
- Review marketing literature for compliance to applicable regulations
- Maintain a thorough knowledge of current regulatory requirements
Desired Profile:
- BS degree in Science or Engineering
- 5+ years experience in Regulatory Affairs in the medical device industry
- Through understanding of international submission requirements including how to comply with standards and regulations
- Must have ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with all levels of personnel
- FDA, EU, Health Canada, TGA, PMDA, and international market submission experience needed
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