Regulatory Affairs Manager

Location: Queensferry, Flintshire, Wales
Salary: £60000 - £80000 per annum + + Benefits
Job Type: Permanent
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Our client is an international medical deice manufacturer focusing on the Ostomy sector. They are looking to hire a pre-market Regulatory Affairs Manager. The primary responsibilities of the position are to ensure regulatory compliance of Ostomy products, drive regulatory pre-market processes ensuring close coordination with Engineering, execution and activities regarding change control, and develop strong working relationships with members of the Ostomy franchise. The Regulatory Affairs Manager will also be responsible for the management of global and regional pre-market regulatory Ostomy projects, including, but not exclusively, the regulatory aspects of new product development, product life cycle, and changes to existing products.

Duties and Responsibilities:

  • The Regulatory Affairs Manager will be responsible for medical device products under development and for product lifecycle changes
  • Work with Ostomy project development teams to ensure global Regulatory Affairs requirements are included in project planning and ensure high quality regulatory compliant pre-marketing documentation is prepared, e.g., for CE marking and 510(k) clearance according to the agreed timeline
  • Make available technical information for international registrations to Regulatory Affairs colleagues supporting commercialisation globally
  • Review sales training, promotional and advertising material, and labelling components
  • Mentor and manage one or more Ostomy Regulatory Affairs Specialists
  • Assist with global regulatory processes, such as Change Control, EU Technical File maintenance, GMDN, UDI, etc

Key Stakeholders

  • Internal - Marketing, Operations, Regional Regulatory Affairs, Research & Development, Quality, Clinical, Business to Business teams
  • External - Competent Authorities, Notified Bodies, other international governmental agencies

Required Skills/Qualification

  • Regulatory Affairs & Quality experience in medical devices (Ostomy preferred)
  • Exposure dealing directly with Notified Bodies, Competent Authorities, and US FDA
  • Hands on track record of creating documentation compliant with FDA CFR 820 and EC Medical Devices Directive 93/42/EEC
  • Knowledge of compliance with key international standards such as ISO 13485 and ISO 14971

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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