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Job Vacancy - Regulatory Affairs Specialist  
8 month + Contract

About JointMedica

JointMedica is a small and autonomous business which designs and manufactures high classification devices for the Orthopaedic industry. We work in friendly cooperation with respected orthopaedic surgeons, experienced engineers, and a variety of cutting-edge suppliers and partners. We are looking for an enthusiastic and motivated Regulatory Affairs Specialist to oversee our latest CE submission for a Class III Medical Device and its associated Instrumentation.

The Role

You will be taking responsibility for developing the required submissions for a number of devices as well as for guiding work to ensure our continued compliance with the latest requirements of the Medical Device Regulations.

Key responsibilities:

  • Production and review of Design Dossiers, Technical Files and Device Master Files and Investigator’s Brochure.

  • Communicating with, and engaging outside agencies/regulatory bodies.

  • Preparation of regulatory submissions for further global product registrations/approvals.

  • Preparation of regulatory input for submissions for clinical studies

  • Review and Support of currently approved devices

  • Management of post market surveillance needs

  • Review and update of IFUs, packaging, labelling and marketing literature.

  • Develop and maintain up-to-date legislative, compliance and regulatory knowledge to ensure that our Medical Device, Product Regulatory Affairs policies, procedures and processes are compliant to current standards


The successful applicant will:

  • Be educated to degree level or with equivalent levels of experience, ideally in a related discipline

  • Possess the ability to manage their own time well, & work in a fast-paced environment.

  • Possess a sound knowledge of ISO13485 and the Medical Device Regulations for Class III Devices.

  • Have previous experience in EU Regulatory Filing processes for Medical Devices

  • Have strong written, verbal, and organisational and IT skills
     

Seniority Level - Mid-Senior level

Industry - Medical Device

Employment Type - Contract

Job Functions Regulatory Assurance

To apply please send your CV and covering letter to - cs@jointmedica.com

 

Or Post to:

Jointmedica Ltd

Unit 3, Ball Mill Top Business Park

Main Road

Hallow

Worcestershire

WR2 6LS