Director, Regulatory Affairs
The Director, Regulatory Affairs will be responsible for the preparation and management of domestic and international product submission/registration activities. This includes interpretation of relevant government regulations, review implications of changes of regulations on devices, review impact of product design changes to approved submissions and establishing compliance to these regulations. This position is responsible for the successful implementation of regulatory strategic and operational objectives. Provide regulatory advice and guidance to other members of the regulatory team and to cross-functional departments.
Essential Duties and Responsibilities:
- Manage, direct and support the Regulatory Affairs team. Hire, train, develop, teach, coach, mentor, motivate, discipline, and reward staff members.
- Meet regularly with direct reports to review performance, identify any issues and set expectations of goals.
- Prioritize and plan work activities; adapt for changing conditions.
- Responsible for product submissions, license renewals, periodic updates and registrations with domestic and international regulatory agencies.
- Responsible for assembling required documentation for all classes of medical device; communicate and give guidance to other departments regarding format and timeline expectation.
- Coordinate responses to regulatory agencies and notified bodies as part of the submission and approval processes.
- Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies.
- Review labeling and labels for compliance with regulatory requirements.
- Review and approve Engineering Change Orders in accordance with regulatory requirements.
- Develop Regulatory Key Performance Indicies (KPI), and report KPI on monthly basis. Present Regulatory status during the Quality Management Reviews.
- Establish, manage and maintain Product Safety Board (which includes Healthcare Professionals) and ConforMIS Recall Committee to make field decisions on product performance.
- Maintain regulatory compliance.
- Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations.
- Review, interpret and report to the head of Regulatory Affairs on product specific regulatory issues.
- Acquire and maintain current knowledge of applicable regulatory requirements.
- Interface with other functional departments to influence efficient execution of projects; provide regulatory support on project teams.
- Manage Regulatory department risk assessment review on production and design related changes, as well as related Quality Holds on NMCRs (patient safety determination).
- Manage team of regulatory professionals and provide oversight and guidance on regulatory strategies, submissions, and projects.
- Develop and mentor Regulatory Specialists.
- Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team’s/company’s knowledge of working in a regulated environment.
- Manage team’s employee development and succession planning activities; set performance objectives, provide coaching/guidance, and provide performance evaluation.
- Other responsibilities as assigned.
- Bachelor’s degree or Engineering or Science. Advanced degree preferred.
- Minimum 7+ years of relevant industry experience.
- Regulatory compliance experience in the medical device area preferred.
- RAC certification desired.
Skills, Abilities, and Competencies Required:
- Excellent written and verbal communication skills.
- Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
- Demonstrated ability to monitor own work to ensure quality, accuracy and thoroughness.
- Strong organizational, analytical and time-management skills.
- Able to self-motivate and work both independently and as part of a team.
- Ability to meet timelines and drive regulatory process to completion.
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
- Creates a learning environment, opens to suggestions for improvements.