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Job Details

Senior Manager Regulatory Affairs - Medical Devices

Company: Apex International Recruitment Ltd
Location: Buckinghamshire
Reference: 2909SMRAMD
Closing Date: 02 Jan 17
Type: Permanent
Salary (£): On Application
Benefits: Competitive salary and benefits available

Job Summary:

Full-time permanent position considering candidates at manager or senior manager level within regulatory medical devices. Medical devices and CE Marking experience is essential - Competitive package available

Requirements:

DETAILS:

  • Full-time permanent position
  • Global pharma company
  • Office based in Buckinghamshire
  • Competitive package available

 

THE JOB:

  • The Senior Manager Regulatory Affairs plans and prepares complex regulatory submission documents for regulatory filings  for all medical devices in Europe, Africa and Middle East (EAME); including CE marking and product registrations outside of the EU. Utilizing detailed, in-depth understanding of medical device regulations, provides global project and regulatory teams with timely input and guidance. Supports management with implementation of departmental strategies and policies.
  • This person will be the CE Mark lead for EU registrations.
  • They will be working on all classes of device but predominantly class 3
  • EU experience is essential.

Full details available on application

THE CANDIDATE:

  • A minimum of BS degree or equivalent in a scientific field, plus appropriate experience in regulatory affairs;  the length of which is dependent on the level of qualifications achieved.
  • Sound Medical Device experience, including a successful track record in the registration and maintenance of products within Europe.
  • Regulatory affairs background in pharma or devices
  • Sound knowledge of relevant Quality Standards. Direct interaction with competent authorities and Notified Bodies.
  • CE Marking Experience essential

 

HOW TO APPLY: Interested? – send us your CV now using the Apply button below!!!

However, if this role doesn’t suit your current skill-set, please call Alex on 01227 844466 for further advice.

Only candidates with existing permission to work in the EU can be considered.

About Apex: Apex International is a professional, knowledgeable and niche recruitment agency who recruit across the UK, specialising in  Medical Affairs,  Pharmacovigilance, Regulatory Affairs and Clinical Development (including QA & QC, Clinical Data Management, Health Economics, Marketing and Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers)). For a confidential and professional chat about your job requirements please call Alex on 01227 844466 or email alex@apexrecruitment.com

Our Passion – Your Profession – A consultative approach to recruitment.

We match professional candidates to the best permanent, contract and interim roles in the market

Visit us: www.apexrecruitment.com

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Apply for this job: Senior Manager Regulatory Affairs - Medical Devices

Contact Information:

Address:  Apex International
The Blue Room, Kent Enterprise House, 1 The Links, Herne Bay, Kent,
CT6 7GQ
England
Tel:  01227 844466
Fax:  01227 208590
Website:  Visit Our Web Site

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