Senior Regulatory Compliance Specialist
3 days ago
Cregg Group is looking for a highly experienced Senior Regulatory Compliance Specialist to join our team. As a senior member of our regulatory affairs department, you will be responsible for leading the research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
The ideal candidate will have a strong understanding of regulatory guidelines and regulations, including ISO 10993, FDA regulatory requirements, European Medical Devices Regulation (EU MDR), and international regulatory agency requirements. You will work closely with cross-functional teams to ensure compliance with regulatory requirements and provide support to the functional project teams on biological evaluations for new and existing products/indications.
Key Responsibilities:
- Lead the research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products
- Respond to requests from notified bodies, competent authorities, and/or distributors to prepare and submit documentation for marketing approval
- Coordinate multiple projects at one time and provide regular reports to regulatory management and others as required
- Provide regulatory direction to development project teams as a core team member
Requirements:
- Level 8 Degree or Masters in Science or Engineering or similar
- Minimum of 5 years experience in a similar role in the medical devices industry
- Strong understanding of regulatory guidelines and regulations
- Excellent leadership and project management skills
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