Senior Regulatory Affairs Specialist-contract

Description

The Regulatory Specialist is responsible for:

Ensuring continuous compliance with the following:

• FDA Quality System Regulation 21 CFR 820 (QSR)
• Medical Device Directive
• HealthCanadaMedical Device Regulations
• ISO13485 Medical Device Quality Management System
• ISO14971
• Pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169 and product related standard

2. Assistance with regulatory submissions for:

• CE registration
• 510(k) registration
• Annual reports,
• Supplements and registrations.

3. Process customer regulatory requests Skills and Experience: 2/3 years experience in a Regulatory Affairs role in the pharmaceutical medical device sector essential, preferably in an FDA regulated environment