The Director, Regulatory Affairs is the key liaison between the Regulatory Affairs & Quality department and our client's international subsidiaries and distributors with respect to developing strategies for in-country regulatory approvals and registrations, implementing quality management system activities and providing post market support. This role currently supports the Europe, Middle East, India, Africa (EMEIA) and Latin America (LA) regions.
Roles and Responsibilities
- Partner with domestic and international teams to develop and execute regulatory and quality management system strategies.
- Ensure processes and documentation are in accordance with international guidelines and company policies
- Act as a liaison between the EMEIA headquarters, corporate headquarters and other international sites in support of regulatory and quality system activities
- Manage responses to questions and issues raised during review of submissions and regulatory inquiries
- Develop and maintain processes for obtaining and maintaining regulatory filings and approvals
- Maintain filing updates and status for distribution, including introduction of new instruments and product modifications
- Identify and develop processes to support compliance activities related to field actions and complaint reporting
- Manage internal and external audits related to the regions
- As needed, provide support to clinical activities
- Provide leadership and direction to the EU-based Regulatory Quality team
Education - Bachelor's degree
Experience: at least 8 years’ experience in medical device field, with experience in the following areas:
- Familiarity with Medical Device design history documentation and process
- Very good understanding of the EU Medical Devices Directive as well as regulatory submissions and compliance requirements
- Experience in developing quality management systems (ISO 13485) and implementing processes
- Demonstrated cross-functional teamwork skills
- Strong computer skills including proficiency with data analysis programs
- Ability to manage direct reports, including remote employees
- Excellent and demonstrated written and verbal communication skills - requires ability to communicate with distributors and regulatory bodies in other countries.
- Excellent project management skills