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Job titleSenior Regulatory Affairs Specialist
Job typeMeditech
Salary GBP
LocationUK Wide
Bonus Package
Job description

Do you want to work for a well-respected medical devices company? Are you experienced in regulatory affairs with knowledge of international standards? We are currently recruiting for a market-leading therapeutics organisation who are looking for a Senior Regulatory Affairs Specialist to join their team in the UK.

The company

Our client are a global medical and technologies company who manufacture and market innovative medical products focused on therapies for the management of chronic conditions. They work across four markets – advanced chronic and acute wound care, ostomy care, continence and critical care and infusion devices used in the treatment of diabetes and other conditions. This is a brilliant opportunity to join a company supported by a fantastic research and development branch who are constantly innovating.

The role

Regulatory affairs is one of the biggest areas in the medical device space right now. This is a brilliant opportunity to be involved in supporting the business by providing specialist medical device regulation resource both pre- and post-market. You’ll be focused on ensuring the regulatory compliance of the company’s product portfolio by managing regional and global regulatory projects that revolve around product lifecycles and regulatory processes.

Main responsibilities include:

  • Ensure regulatory compliance for the Ostomy portfolio
  • Leading on product lifecycle and regulatory processes
  • Reviewing new product listings and delisting
  • Registration of new manufacturing sites into databases
  • Completing enquiries and requests from internal and external stakeholders
  • Reviewing and approving change control requests
  • Developing relationships with internal and external stakeholders
  • Executing and managing post-market activities such as recalls and corrections
  • Create, develop, and maintain regulatory documentation (predominantly for Class II or Unclassified products for the US market)
  • Work with Project Development teams to comply with regional regulatory requirements
  • Prepare pre-market documentation for CE marking and 510k
  • Liaise with regulatory bodies on compliance of existing and new products
  • Assist with global regulatory processes
  • Create innovative process

The requirements

You will have as least five years’ experience in a regulatory affairs role in the medical devices market as well as…

  • Bachelor’s Degree in a science, engineering, medical technology or nursing
  • Regulatory Affairs Certification preferred but not essential
  • Demonstrable track record in regulatory/quality in medical devices
  • Specific experience of driving MDD through to MDR regulations
  • Working experience with FDA regulations
  • Experience in both pre- and post-market activities
  • Experience with Class I, II, and III products
  • Experience with electronic submission
  • Experience dealing with Notified Bodies, Competent Authorities and the US FDA
  • Knowledge on international standards (ISO 13485 and ISO 14971)
  • Document creation experience (compliant with FDA and EC guidelines)
  • Strong interpersonal skills
  • Able to deal effectively with a variety of stakeholders in different business areas
  • Ability to effectively prioritise workload
  • Excellent communication skills (both written and verbal)

 

Important information

FMC contact for this role: Rhys Miller (rhys.miller@fmctalent.com)

Reference number: 9007

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