Regulatory Affairs Professional – Europe

A Global Market Leader in In Vitro Diagnostics has three immediate openings in Europe for a Regulatory Affairs Professional.

Job #1:  You will be responsible for planning, developing, and preparing regulatory strategies and submissions aimed at achieving marketing approvals or clearances for new and modified products in the US. Ideal candidate is familiar with software for diagnostic analyzer systems, new product entry into US market, US submissions (pre-IDEs, 510(k)s, and PMAs) and/or interfacing with the FDA. 

Job #2:  You will be responsible for planning, developing, and preparing regulatory strategies and submissions aimed at achieving marketing approvals or clearances for new and modified products in the US. Prefer candidates with background in diabetes care diagnostics and/or infusion pump systems and knowledge of the PMA process.

Job #3:  You will provide technical direction to complete international submissions required in order to market products internationally.  Prefer candidates with direct interface experience with global regulatory bodies and/or registration experience (Asia, Latin America, and/or EU).

 The facilities are located in Germany and/or Switzerland. 

 Requirements

  • Must have a Bachelor’s degree in a scientific discipline or equivalent combination of education and experience.
  • Minimum 5 years regulatory experience in medical devices and/or IVD devices.
  • Must have excellent verbal and written communications skills.
  • Ability to work in a fast-paced, technically challenging environment.
  • Must be self-motivated, self-disciplined, and able to prioritize and handle multiple tasks and responsibilities.
  • Effective interpersonal skills/diplomacy and problem solving techniques.
  • Excellent applied thinking and technical writing skills.

Candidates must also pass a drug and background screen.  Beaufort offers competitive salary and benefits, including but not limited to medical and dental coverage and paid time off.

E-mail your resume with subject line Regulatory Affairs Professional-Europe to jobs@www.beaufortcro.com.  Beaufort, LLC, is an Equal Opportunity Employer.