SENIOR Regulatory Affairs Specialist. In your new role as Senior Regulatory Affairs Specialist (m/f)

Description

Our client, a MedTech company, is currently looking for a SENIOR Regulatory Affairs Specialist. In your new role as Senior Regulatory Affairs Specialist (m/f) you organize and implement strategies and activities required to procure regulatory approval for new surgical robot.

Responsabilities:

  • You ensure compliance to all US, EU and international requirements and corporate policies and procedures regarding submissions and other requirements for market approval of medical devices products
  • Prepare complex submissions to gain approvals
  • Coordinate,prepare document packages for regulatory submissions in one or more of the following geographic regions: United States, Europe, Asia…
  • You interface, coordinate and negotiate with the FDA, EU and other regulatory agencies on submissions, approvals or other issues
  • You support R&D, marketing and manufacturing teams in regulatory assessment of proposed changes or product transfers
  • Moreover, you participate in cross functional team activities from initial stages through securing government approvals for any initiative and project requiring Regulatory Affairs support
  • Ensure that existing approvals and documentation are maintained.
  • Develop global regulatory strategies for project teams
  • Provide input on and reviews protocols and reports
  • Monitor, research and obtain information on FDA OR CEE clearances/approvals of competitors, and proactively shares this information with the R&D teams
  • Communicate, plan, and execute meetings with regulatory agencies and investigators

Profile:

  • Bachelor’s degree (B.S. or B.A.) in Engineering, Science or related​ / RAC certification or Advance Degree (Master in Regulatory Affairs) preferred​. 8+ years’ experience in a medical device environment​ with demonstrated success in management of global regulatory submission activities​. Demonstrated applied knowledge of FDA and international medical device regulations/standards/directive (i.e. 93/42/EEC (Medical Device Directive, etc.)​
  • You have successfully interacted with FDA and notified body reviewers/inspectors and you have a sound understanding of scientific principles
  • Adaptable to a fast paced environment with changing circumstance and has the desire to thrive in a dynamic environment
  • Good time and project management skills with the ability to multi-task​
  • You are characterized by strong interpersonal and communication skills. Moreover, you have excellent organizational and planning skills

You are fluent in English and have ideally a good knowledge of French, and able to travel regularly.