Regulatory Affairs Coordinator

Location: Chesham  |  Buckinghamshire  |  England
Sector: Life Sciences
Consultant: Harvey Havell
Job Reference: HH/HQ451
Salary: £35000 - £40000
Job Status: Permanent / Full Time

Regulatory Affairs Coordinator

Full-time permanent position

Based in Chesham, Buckinghamshire

Office-based role

Salary range: £35-40,000 per annum

Reporting to the General Manager

My client, a medical devices company specialising in cancer surgery are looking for a Regulatory Affairs Coordinator to join their growing team.

Key duties of the job include:

  • Prepare and maintain the Products technical files, including updating in line with engineering changes and annual reviews for inclusion of post market data
  • Manage risk management throughout product development projects and after product release to include running meetings, updating registers and risk management planning
  • Engineering change note releases to include ensuring risk has been reviewed, release process followed, and tech files updated
  • Responsible for development project documentation registers to include providing information supplemental to project plans regards the documentation required to complete each milestone and working with Engineers to ensure documents are completed
    • Manage product development ‘phase exits’ to include collating documentation specified in internal processes, putting together presentations and delivering this to senior management team for stop/go project decisions.
    • Specify products storage, labelling and packaging requirements, writing comprehensible, user-friendly, clear product information leaflets and labels
    • Liaise with, and make presentations to, regulatory authorities

Skills required:

  • keep up to date with national and international legislation, guidelines and customer practices
  • ability to collect, collate and evaluate data from a range of sources
  • maintaining familiarity with company product ranges
  • analyzing sometimes complicated information, including trial data
    • providing advice about regulations to engineers Education and experience:
    • Degree level is preferred
    • 3 years’ experience in medical devices (preferably with exposure to product development)

If this is the right job you’re looking for please click apply now to submit your CV.

About Seven

You will be working alongside the fastest growing recruitment company in the UK, who provide an unrivalled service to all of their clients and candidates across the United Kingdom. Seven currently offer the best contractor pay rates in the UK for Life Sciences, making us the best option for maximising your earning potential and career fulfilment. Seven Consultants are passionate about placing you in the best possible role, for the best possible rate, while providing a support platform, which is accessible around the clock.

Are you ready for the challenge? If so, we look forward to hearing from you.

What else can you expect from Seven?

– Specialist Consultant allocated to you with all the expertise you require.

– Excellent Payroll and Compliance System, ensuring that you are paid on time, every time.

– Access to Exclusive Rates, allowing you to gain earnings that no other agency can offer you.

– £250 Referral Bonus for every person you successfully refer to Seven.

If you are interested in this opportunity, please call 020 3887 7365. Please ask for Harvey Havell in the Life Sciences team