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Fastnet The Talent Group

Job Title

Regulatory Affairs Specialist


The Regulatory Affairs specialist will primarily be responsible for ensuring compliance to all relevant regulations which includes the maintaining all quality systems and related documentation. Responsibilities. Ensure continuous compliance with the following: FDA Quality System Regulation 21 CFR 820 (QSR), Medical Device Directive, Health Canada Medical Device Regulations , ISO13485 Medical Device Quality Management System , ISO1497 and Pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169 and product related standards. Assist with regulatory submissions within: European Union (Class IIa, Class III), United States (Class II, 510k), Annual reports and Supplements and registrations. Assist with preparation and closing activities associated with: United States FDA inspections , ISO 13485 audits (see appendix 1 for details), Other Regulatory Agency Audits and Internal audits (see appendix 1 for details. Process customer notification and regulatory requests. Support Quality system and regulatory system improvements activities. Support, Maintain and Develop document control system. Requirements. Engineering or science degree or equivalent experience. 1-3 years experience in a QA role in the pharmaceutical, healthcare or medical device sector essential, preferably in an FDA regulated environment. Ability to communicate and work with people inside and outside the department. Ability to co-ordinate, plan and organise. Rigorous attention to detail. Excellent attention to detail and organisation skills. Ability to work to deadlines and on own initiative. Excellent interpersonal skills. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on



Date Added

109 days ago