• Careers

    Find out from some of our valued team members about what it's like to working with us and what makes SFM so great.

Careers

Find out from some of our valued team members about what it's like to working with us and what makes SFM so great.

SFM is a leading supplier of substrates and products to the advanced wound care market

Graeme Kettlewell

"SFM's world leading technical capabilities are the foundation of our approach to innovation as we develop and enhance existing and new products to satisfy the requirements of healthcare professionals."

Kevin Graham

"I get a real sense of achievement working with my colleagues at SFM with the aim to provide products and services to satisfy our customer needs and also meet quality, safety and reliability expectations."

Irina Savin

"I like working at SFM because I love helping people and I know that what we’re doing here is to make patients' lives better and less painful with our products.”

Current Vacancies

Regulatory Affairs Manager
Summary

This role is responsible for supporting the company’s regulatory function. This will be achieved through leading SFM’s product submissions for key global territories and also supporting SFM’s customer’s regulatory requirements.

Key Roles and Responsibilities
  • Drive the development global regulatory strategies for SFM’s submissions for new and modified products
  • Drive the development and execution of all regulatory submissions including 510(k) submissions, and CE Mark Technical Files and Design Dossiers
  • Work closely with the R&D function; act as the RPL in business projects supporting the delivery of relevant outputs from the project and managing the regulatory project
  • Working with our Commercial function, agree priorities and interface with our customers to support their regulatory and strategies
  • Maintain Notified Body Approval for the portfolio of medical devices
  • Ensures the technical files/design history record/device master record are in a state of audit/inspection-readiness
  • Advise/act on implications of new or amended standards relevant to the medical devices manufactured by the business or SFM’s customers
  • Maintain compliance and improvement to the business compliance and quality systems including the risk management programmes
  • Support the management of communication with Regulatory Authorities, and Notified Bodies to address RA questions and submission issues
  • Contribute to create and maintain a proactive quality culture throughout SFM and assist quality activities to achieve the standards of excellence as set out in the company’s quality policy, and shares best practice where possible
The ideal candidate will have:
  • Regulatory, science or engineering degree or equivalent
  • Knowledge of the Medical Device Directives 93/42/EEC, 21 CFR 820, Regulation EU 2017/745/EEC
  • Ability to gather, analyse and interpret regulatory information and changes in the regulatory landscape
  • Understanding of device classification MDR for Europe, for the USA
  • Pragmatic team member and flexibility to work within the dynamics of a cross-functional team

Apply Now

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