Ability Matters Group is a leading provider of specialist prosthetic, orthotic, and mobility services throughout the UK and Ireland. With over 25 years of experience in the industry, we work continuously to deliver the highest standard of care possible to ensure customer needs are met.
This is a newly created position for a motivated and experienced Regulatory Affairs Specialist to join the business, reporting into the Head of Quality. The successful candidate will play a pivotal role in helping assure continued compliance with changing regulatory requirements, as well as supporting the organizations global growth.
Have a background in medical device regulatory affairs/compliance
Have experience of preparing and maintaining technical documentation for CE marking
Are knowledgeable in medical device vigilance requirements
Have excellent attention to detail
Enjoy working for an organization that manufacture products that really help patients
…we want to hear from you!
Forming an integral part of the growing Quality & Regulatory Department, the role holder will primarily:
Compile and maintain appropriate technical documentation for regulatory submissions and to support CE marking
Perform regulatory compliance audits within the organization
Be actively involved in the transition from MDD to MDR
Coordinate all FSCA/FSN activities
Participate in cross-functional product development teams as the regulatory representative, developing strategies and plans as necessary
Participate in the review of process/product changes, labelling, claims, product complaints, advertising & promotional materials), etc., to determine the need for any regulatory activities and to ensure compliance to International requirements
The role is based full-time in Abingdon (Oxfordshire), however given the geographically dispersed operations of the Group, occasional travel will be required within the UK.
We are looking for a methodical team player who has:
Minimum of 2 years’ recent, in-depth knowledge and application of 93/42 EEC and technical documentation
General knowledge of RoW medical device regulatory requirements
Knowledge of medical device vigilance requirements
A high level of integrity.
Excellent interpersonal and communication skills.
Exceptional attention to detail, and an attitude of continuous improvement.
The role holder will be subject to a DBS check prior to commencing employment which must satisfy company standards.