Regulatory Affairs Specialist

1 week ago


South Yorkshire, United Kingdom Austin Vita Full time
Job Description

Austin Vita is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Quality and Regulatory Affairs department, you will play a critical role in ensuring the company's medical devices comply with national and international legislation.

Key Responsibilities:
  • Regulatory Compliance: Manage regulatory affairs objectives to meet the company's Strategic Plan and Department Operational Objectives.
  • Regulatory Leadership: Take the lead in all matters relating to regulation and applicable legislation, including the development, management, and maintenance of Technical Files and Design Dossiers.
  • Product Clearance: Responsible for the maintenance of Product Schedules with device classifications and allocating new GMDN codes, as well as leading the Regulatory Affairs Team in new country product application to market.
  • Regulatory Advice: Provide regulatory advice to other departments and Project Teams as and when required.
Requirements:
  • Education: Degree educated or equivalent in a life science or engineering discipline.
  • Experience: At least five years' experience in a life science regulatory environment, ideally working with Class III Devices.
  • Regulatory Knowledge: In-depth knowledge of international regulatory requirements for placing medical devices in UK, EU, North America, South America, the Baltics, and Asia-Pacific markets.
  • Management Systems: In-depth knowledge of Management Systems, particularly ISO 9001, ISO 13485, RDC 59/2000, ISO 14001, OHSAS 18001, 21 CFR Part 820 & Part 11.
  • Leadership Skills: Strong leadership and influencing skills, with the ability to work on own initiative and lead successful cross-functional teams.


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