Job Vacancy - Regulatory Affairs Specialist
8 month + Contract
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.
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.
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 - firstname.lastname@example.org
Or Post to:
Unit 3, Ball Mill Top Business Park