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.
- 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
- 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.