Regulatory Affairs Manager

Position: Regulatory Affairs Manager Location: Gloucester Job Type: Permanent / Onsite Our client, a global leading manufacturer in the medical device industry are on the hunt for a Regulatory Affairs Manager. Role and Responsibilities – In this role, You will ensure business compliance, regulations and quality standards in support of the companies overall goal. This will be to maintain the correct market access for the device internationally. Other responsibilities include:

• Maintain up-to-date knowledge on both domestic and International Regulatory requirements, effectively communicating to management and project teams.
• Support the process to ensure the Quality Management System is maintained in accordance with relevant regulatory/statutory requirements (including ISO13485, 21 CFR 820, MDD 93/42/EEC, Regulation (EU) 2017/745 and ISO14971)
• Issues advisory notices as required, in accordance to the MDD, MDR, and FDA regulatory requirements (21 CFR 803)
• Develop, prepare, and maintain high quality technical files, design dossiers and other necessary applications for regulatory submissions and approvals

Experience or Qualifications –

• Proven experience within regulatory affairs with an extensive amount being in a managerial position
• Medical Device experience is essential
• Lead Auditor training
• MDR experience strongly desirable

Benefits –

• 25 days annual leave + Bank Holidays
• Private Health Care Options
• Employee Assistance Programmes
• Competitive Pension Scheme

Candidates who currently are a Regulatory Affairs Manager, Compliance & Regulatory Affairs Manager, Regulatory Affairs Director or Regulatory Affairs Specialist may be suitable for this position. For more information regarding this Regulatory Affairs Manager role please contact Ben Herd on 01453 829523 or ben.herd@omegaresource.co.uk Omega Resource Group is acting as an Employment Agency in relation to this vacancy. Omega Resource Group is an employment agency specialising in opportunities at all levels within the Engineering, Aerospace, Automotive, Electronics, Defence, Scientific, Oil & Gas, Construction and Manufacturing sectors. For details of other opportunities available within your chosen field please visit our website