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Medical Device Regulatory Manager

Employer
CK Group
Location
Reading
Salary
Up to £50,000 per annum
Closing date
20 May 2021

Job Details

CK Group are recruiting for a Medical Device Regulatory Manager to join a specialist Ophthalmology company in the latter stages of bringing a new medical device to market. When safe to do so the role will be office based in Reading for two days a week.

Salary:

Base salary of up to £50,000 per annum.

Medical Device Regulatory Manager Role:
As Medical Device Regulatory Manager you will be joining a high-performing team and playing a key, strategic role in ensuring the successful commercialisation of their medical device portfolio.

Key duties will include:
  • Providing regulatory advice and expertise in relation to identifying and implementing changes required to the company's quality management system (QMS) in order to maintain compliance with the regulations of all appropriate authorities.
  • Creating and reviewing of Standard Operating Procedures (SOPs).
  • Monitoring medical device regulatory changes and coordination/implementation of appropriate procedural changes within the QMS.
  • Assisting in compiling and updating technical files for new medical device product submissions and registrations. Working closely with all third parties in the process.
  • Management and organisation of internal and external audits. Co-ordinating review of the results ensuring all actions are agreed and implemented in the timescales set.

Your Background:
As Medical Device Regulatory Manager you will require:
  • A relevant Scientific or Technical degree.
  • A detailed knowledge of US, UK and EU pharmaceutical and medical device regulations.
  • Extensive US and EU regulatory affairs experience in the medical devices field, including Technical File creation, classification, registration and Notified Body submissions.
  • Experience of QMS management.

Apply:
For more information or to apply for this Medical Device Regulatory Manager position, please contact CK Group, quoting job ref 50009.

It is essential that applicants hold entitlement to work in the UK.

Company

Find the career you always dreamed of

We are the CK Group, the UK’s specialist in scientific, clinical and technical recruitment.

We have 4 brands:  

  • CK Science is the leading independent scientific recruitment consultancy.
  • CK Clinical is an established leader in the clinical research and drug development sectors
  • CK Technical specialises in jobs for Engineers and IT professionals
  • CK QLS finds roles for high calibre professionals working in the science and technology sectors in Switzerland.

Over the last 28 years we have found jobs for thousands of high calibre scientists in the scientific, chemical, waste, biotechnology and pharmaceutical industries. By working with us to find your next job, you will get access to the best scientific vacancies in the UK, Europe and the rest of the world.

We are proud to be working with 18 out of the world’s top 20 scientific organisations.

We can help you find your dream job.

ckscience.co.uk

Company info
Website
Telephone
+44 (0)1246 457700
Location
CK Group
Westwick House
The Bridge Business Centre
Beresford Way
Chesterfield
S41 9FG
GB

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