Regulatory Affairs Director
- Job Level:
Medical Device Firm in Westport, CT is seeking a Hands-on Senior Director who is responsible for the Regulatory Affairs and Quality Assurance strategy, policies, and procedures to ensure the company follows all domestic and international guidelines and regulations.
The Senior Director, Quality Assurance & Regulatory Affairs will be responsible for:
- Developing FDA and ISO 13485 complaint QMS that is relevant to our business model. Including but not limited to Design Controls, Supplier Quality, Management Controls, Complaint process/MDR, Recall, Material Review Board, Field Actions, CAPA, Internal Audit etc.
- Responsible for the development of regulatory strategies that ensure compliance to US and International Quality System requirements, product registration requirements and clearance/approval.
- Will be actively involved with the turn-key suppliers and be responsible for Supplier Quality Assurance and Product Quality Will be involved and provide input and direction to our Clinical Advisory Board and help oversee all clinical plans and trials.
- Provide assessments and recommendations on non-conforming materials and product quality issues and regulatory compliance.
- Will review, improve and critique all Risk Management, Verification and Validation protocols, procedures and reports.
- Identifies, analyzes and documents problems and works with the respective teams for proper resolution.
- Conducts internal audits and facilitates external inspections.
- Will work directly with our Regulatory and Quality Assurance consulting teams. Review and approve Marketing/Sales advertising and collateral material ensuring regulatory compliance.
- Secure and maintain ISO 13485 certification
- Bachelors degree in engineering and/or business, or equivalent experience.
Experience & Skills Required
- 15 years of Quality Assurance, Quality Engineering and Regulatory experience in a FDA environment, preferably Medical Devices, Gastrointestinal.
- 5 years of Regulatory experience with new product introductions and dealing with the FDA. Preferred Field of
- Expertise: Turn-key Supplier Management of R&D and Production on hand held Medical Devices.
- Direct experience working with the FDA and external regulatory consultants.
- Technical emphasis should be with all types of plastic processes, cabling and small mechanical parts.
- Essential Knowledge, Skills and Abilities Proficiency in FDA regulatory requirements, quality assurance, risk management, verification and validation processes and ISO 13485
- Can effectively work with turn-key suppliers and R&D teams