Job Function: Manage/perform regulatory activities and develop regulatory strategies for obtaining worldwide product approvals for a variety of medical devices, biologics, technologies, and clients.
General Functions:
- Independently prepare U.S. regulatory submissions including 510(k)s, IDEs, PMAs, PMA supplements and periodic reports.
- Independently prepare international regulatory submissions and registrations.
- Interact/negotiate with FDA and other worldwide regulatory agencies regarding product approvals.
- Collaborate with Clinical Affairs in developing clinical protocols and preparing regulatory documents.
- Represent regulatory affairs on project teams and establish appropriate regulatory strategies.
- Manage/maintain regulatory submissions and records.
- Manage/generate departmental procedures.
- Perform searches/analyses to address specific regulatory questions or issues.
- Advise clients on FDA device listing, facility registration activities, labeling, and regulatory compliance issues.
- Coach regulatory staff.
Expected Areas of Competence:
- Demonstrated knowledge and experience with U.S. and international device and biologic regulations.
- Demonstrated success in setting regulatory strategy and in obtaining worldwide product approvals, particularly those involving complex issues
- Detail-oriented with ability to accomplish objectives with minimal supervision.
- Competence in applying scientific principles and logical thought processes in preparing regulatory documentation.
- Ability to interact effectively in a team environment.
- Proficiency in basic personal computer skills including electronic mail, record keeping, routine database activity, word processing, spreadsheets, graphics, etc.
- Advanced written and oral communications, technical writing and editing skills
- Strong organizational skills, able to manage multiple projects and clients with shifting priorities
- Proficient knowledge of medical terminology, practices, regulations and procedures
- Expertise with regulatory compliance, including post approval change controls and field actions
- Knowledge of clinical trial strategy and study design, statistical methods and outcomes research
- Self-directed individual, able to take the initiative and handle ambiguity
- Able to manage complex problems/projects by exercising independent decision making and analytical thinking skills
- Ability to travel (approximately 10%).
Education, Training and Experience Required:
- Bachelor’s degree (technical). Technical degree defined as engineering, biological sciences or related medical/scientific field
- More than ten years Regulatory Affairs experience directly supporting regulatory affairs in the medical device sector. Minimum three years experience with Class III devices.
- More than 3 years people management experience.
- R.A.P.S. certification a plus
