Regulatory Affairs Manager (Medical Devices)
Reports to Director of Regulatory Affairs
***Will consider remote for the right candidate. If remote, will be required to travel to the Tri-Cities/Johnson City area as required. Approximately 25%.
Essential Roles and Responsibilities:
- Provide guidance to product core teams to ensure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements. Provides regulatory opinion for complex or unique issues and challenges regarding registration and compliance activities. Reviews, interprets, and communicates FDA/international regulations and guidance documents to ensure complete and scientifically sound product submissions.
- Prepare pre-market submission reports / technical files / clinical trial applications per the requirements of key regulatory agencies (e.g. FDA, Health Canada, EU).
- Evaluate competitor products using current regulations to help identify predicate devices for future product development and submission requirements.
- Coordinates regulatory issue resolution using internal resources, regulatory agencies, and outside consultants as needed.
- Identifies and drafts domestic and international strategies, registration plans and options to obtain product approvals and support product changes.
- Regulatory review of post-market product changes and decision on appropriate mechanism for change control (e.g. internal documentation, notification of change, supplemental submission).
- Advise on impact of regulations, devises strategies for compliance and acts as liaison with regulatory bodies for facility inspections, licensure and permits.
- Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team’s knowledge of working in a regulated environment.
- Assist in the update, enhancement, and creation of internal policies and procedures.
- Supports regulatory compliance to QSR, ISO, FDA, and other worldwide regulatory requirements as appropriate through customer complaints, internal audits and training systems.
- Perform other duties as assigned.
Job Related Qualifications/Skills:
- Any combination of education and experience equivalent to a bachelor’s degree in life science; advanced degree preferred.
- Minimum of 5 years Medical Device Regulatory Experience required; aesthetics experience preferred
- Solid understanding of cGMP for Medical Devices, ISO 13485, FDA and (New) EU Medical Device requirements
- CE Mark product certifications experience