Position Overview

Responsible for managing and providing strategic and tactical direction for Regulatory Affairs activities company-wide. Design and implement regulatory strategy through cross-functional engagement and management of a team of RA professionals. Typical duties:
  • Provide regulatory insight to define platform portfolios and strategies for the business. Actively partner cross functionally with groups such as R&D, Marketing, Clinical Research and Quality in this responsibility.
  • Lead a team of RA professionals to define global regulatory strategies and application of the strategies to align with the business plans across a platform of products.
  • Lead a team of RA professionals in obtaining regulatory approvals for Class II and Class III medical devices.
  • Serve as the main RA liaison with cross functional partners and other parts of the RA department to execute platform portfolio strategies.
  • Serve as main contact with US Food and Drug Administration (FDA) and notified bodies as well as liaise with other country Regulatory Agencies when needed, directly or in coordination with local country representation.
  • Work collaboratively with Marketing organization to review and approve effective and complaint company and product promotional materials, including defining and revising RA processes for such review as necessary.
  • Actively engage in RA Policy efforts relevant to the company and products through participation in industry-wide committees.
  • Lead and support department wide improvement projects.
  • Develop regulatory talent within the organization by setting goals, monitoring performance, coaching, and mentoring RA associates.
  • Perform additional responsibilities as assigned.

    1. Minimum BA/BS degree in a scientific or technical discipline or other relevant field of study.
    2. Twelve (12) to fifteen (15) years of professional regulatory experience in medical devices.
    3. A minimum of five (5) years of management experience.
    4. Knowledge of medical devices regulations, trends, and developments impacting company operations and products worldwide.
    5. Hands-on experience with 510(k), PMA, and Technical File/Design Dossier submissions (PMA experience is essential).
    6. Experience interfacing with relevant regulatory authorities through all stages of device life cycle.
    7. Excellent written and verbal communication skills.
    8. Proficient with MS Word, Excel, Outlook, and Teams.
    Desired Qualifications
    1. Master’s degree preferred.
    2. Effective facilitation skills to motivate multi-functional groups and proven effective leadership skills to guide and mentor team members.
    3. Demonstrated ability to work effectively with a variety of work groups including multi-national teams to assure conformance to regulatory requirements, internal processes, and procedures.
    4. Excellent interpersonal communication, collaborative teamwork, and negotiation skills.
    5. Demonstrated project management and organizational skills.