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Job titleRegulatory Affairs Specialist
Job typeMeditech
Salary30,000 - 35,000 GBP
LocationUK Wide
Bonus Package10%
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 Regulatory Affairs Specialist for their Ostomy division.

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.

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 Ostomy branch of the business by providing specialist medical device regulation resource. You’ll be focused on ensuring the regulatory compliance of the company’s ostomy 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
  • Developing relationships with internal and external stakeholders
  • 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 a strong knowledge of regulation in the medical devices market as well as…

  • Bachelor’s Degree in a life science (or equivalent)
  • Demonstrable track record in regulatory/quality in medical devices
  • 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: 9009

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