Join a rapidly growing firm based in Washington DC area with revenues in excess of $100M/yr. The company manufactures cutting edge medical devices including high-tech biological detection instruments / products while providing unique solutions and information resources for scientists working in medical research.

Duties:

·          The Manager of Regulatory Affairs is responsible for the company’s regulatory filings. Strong and continually updated consciousness / understanding of the regulatory requirements both in the US and the international community that are posted by appropriated regulatory organizations, such as the FDA, is expected. This professional is responsible for FDA, CMDR, MDD and ISO compliance documentation.

·          Overseeing full company / department compliance with the appropriate regulations

·          Act as in-house expert in legal matters and coordinate the company response to audits or regulatory issues.  

·          Handles documentation and issues related to 510k’s, IDE’s and related.

·          Helps develop procedures and strategies related to regulatory approval for new product introduction both in the US and the international community.

Requirements:

• Bachelor’s degree preferably in Life Sciences
• Seven years of regulatory affairs experience
• Experience with FDA regulated employer(s), and a good understanding of international regulatory requirements for medical devices, including 510K applications
• Regulatory planning experience with 510(k), PME and IDE submissions is desirable.
• Medical Device trials and pharmaceutical products related experience is desirable.
  

Send a word resume to jthompson@tescareers.com
Jeff Thompson
TES, Inc
440-266-0022 ext 104