Job Title: Regulatory Affairs Director (RAD)

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

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