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Job titleSenior Regulatory Affairs Specialist – Continence and Critical Care 
Job typeMeditech
Salary GBP
LocationUK Wide
Bonus PackageBonus 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 Regulatory Affairs Specialist for their Continence and Critical Care division. 

 

The company 

Our client is a global leading medical device and technologies company who manufacture 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. 

They are focused on sustainable performance and continuously strive for an innovative, excellent portfolio of products. 

 

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 Continence and Critical Care branch of the business by providing specialist medical device regulation resource. You’ll be focused on ensuring the regulatory compliance of the company’s Continence and Critical Care product portfolio by managing regional and global regulatory projects that revolve around product lifecycles and regulatory processes. 

Main responsibilities include: 

  • Ensuring regulatory compliance for the Continence and Critical Care portfolio 

  • Leading on product lifecycle and regulatory processes 

  • Developing relationships with internal and external stakeholders 

  • Creating, developing, and maintaining regulatory documentation (predominantly for Class II or Unclassified products for the US market) 

  • Working with Project Development teams to comply with regional regulatory requirements 

  • Preparing pre-market documentation for CE marking and 510k 

  • Liaising with regulatory bodies on compliance of existing and new products 

  • Assisting with global regulatory processes 

  • Creating 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 subject (or equivalent) 

  • Demonstrable track record in regulatory/quality in medical devices 

  • Experience dealing with Notified Bodies and Competent Authorities 

  • Experience of transitioning from MDD to MDR 

  • Strong experience with and knowledge of 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 

  • Able to work independently and autonomously  

  • Excellent communication skills (both written and verbal) 

 

This role is a remote-working position. 

 

Important information 

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

Reference number: 10147 

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