Could this be your next job?

Share job via email

Job titleRegulatory Affairs Specialist
Job typeMeditech
Salary GBP
LocationUK South
Bonus Package
Job description

Do you have experience working in regulatory affairs in the medical devices space? Are you looking for the next step in your career? We are currently supporting an incredibly well-respected, market-leading medical device company that is looking for a Regulatory Affairs Specialist to join their team based in the South East of the UK.

The company

Our client is a dominant market leader in providing solutions that improve medical discovery, diagnostics and delivery of patient care. Their core focus is on making sure healthcare professionals, pharmaceutical providers and industry partners have the innovative technologies to help advance clinical therapies for patients, clinical process and workflow.

The role

Regulatory affairs is one of the biggest areas in the medical device space right now. This is a brilliant opportunity to join a leading medical device organisation’s regulatory team. As a Regulatory Affairs Specialist you’ll use your knowledge of the regulatory landscape to ensure products are developed, manufactured, and distributed according to required regulations and standards.

 

Responsibilities include:

  • Ensuring products meet regulatory and technical standards
  • Sharing knowledge of regulations
  • Demonstrating compliance with global regulations
  • Preparing data to obtain certifications and commercialization authorisations
  • Leading on the transition of MDD files into MDR technical documents
  • Monitoring progress on the transition from MDD to MDR
  • Registering products under OUS international regulations and country-specific requirements
  • Acting as the regulatory representative in product development teams
  • Reviewing processes
  • Identifying the need for any regulatory activities
  • Attending audits (by both internal and external bodies)
  • Preparing regulatory documentation and dossiers for submission

 

 

The requirements

You will have proven experience in a regulatory role in the medical devices space, as well as…

  • Strong knowledge of scientific, regulatory and business issues
  • Previous experience of ensuring compliance of MDD/MDR devices (of all classes)
  • Excellent knowledge of regulatory frameworks (MDD, MDR, CE marking)
  • Experience in International Standards (ISO 13485 & 14971)
  • Knowledge of IEC 60601 series
  • Knowledge of design control, software lifecycle and risk management processes
  • Understanding of the medical devices space
  • Experience registering medical devices
  • Experience with medical device approval processes
  • Ability to work collaboratively
  • Enthusiastic and motivated to work in a fast-paced environment

 

Important information

FMC contact for this role: Natasha Szombara (natasha.szombara@fmctalent.com)

Reference number: 9199

Share job via email

Oh, and if you are interested in this job…

Telephone us on +44 (0) 1522 695 011 during office hours, or use this form to send us a quick message, and we’ll get back to you.

    First Name (required)

    Last Name (required)

    Your Email (required)

    Job Reference

    Your Message

    Upload/update your CV (optional)

    When you submit this form we will store information about you on our secure system. We will not share this information with any third parties except for the purposes of proposing you as a suitable candidate for roles which match you skills. We may also send you emails from time to time if we think you may be interested in opportunities we are trying to fill. You may unsubscribe at any time. Please refer to our privacy page.

    Please note: some users report the SEND button is slow to respond. When the form is submitted you will see a Success message.

    my new job

    Updated on 2017-08-07T17:04:38+00:00, by Matthew Graham.