Senior Regulatory Affairs Associate

Overview

Austin Vita are delighted to be supporting another of our Medical Device Clients based in North Yorkshire who are rapidly expanding and have a new permanent requirement for a Senior Regulatory Affairs Associate in the Regulatory Team. The opportunity will offer hybrid working and a path to Leadership/Management.

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Responsibilities:

• Management of tasks and requests within the regulatory and quality team to ensure progression and completion.

• Management and tracking of submission of technical files and change notifications to notified body as appropriate.

• Responsibility for creation and maintenance of regulatory documentation for EU, US and rest of world as required.

• Assisting Head of regulatory and quality affairs in the preparation and coordination of annual regulatory system audits.

• Supporting regular internal regulatory system audits.

• Manage Regulatory Affairs Associate, delegate and monitor completion of key tasks and actions. Overseeing all activity and workload, supervising all work conducted where necessary through thorough reviews and checking

• Assist in ensuring compliance of product packaging, labelling and delivery documentation according to the relevant standards.

• Liaise with cross functional senior management team and act as regulatory project lead for new product development and compliance projects.

• Assist Head of Regulatory and Quality Affairs with regular internal regulatory and quality meetings.

• Ensure regulatory technical dossiers are maintained in line with applicable legislation.

• Preparation of documents for regulatory submissions.

• Regulatory inputs on New Product Development.

• Regulatory approval of graphics/packaging/literature.

• To work with Quality Affairs for vigilance, complaints, and post market surveillance activities.

• Responsible for ensuring MHRA and FDA device listings databases are kept current and up to date.

• To raise and/or complete actions as part of change control process.

• Work with cross functional teams to ensure creation and maintenance of technical documentation is completed.

• Responsible for research of applicable FDA product codes for necessary devices, creation of 510ks as necessary, and collaboration with consults.

• Completion of other reasonable tasks that may be asked by Company Directors.

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Knowledge/Qualifications:

Essential -

• Degree or equivalent certification in science related, medical, or engineering discipline.

• Regulatory experience within the medical devices sector (ideally 3 or more years experience)

• Working knowledge of the MDR, ISO 13485 and related ISO standards.

• Experience in the compilation and review of Class I, IIa, IIb and III EU technical documentation for CE marking

• Experience in the compilation and review of 510ks.

• Have the ability to assess all necessary and specific medical device regulatory obligations and to be able to advise staff and customers accordingly.

Desirable -

• Experience of conducting/managing Internal & External audits.

• Experience of sterilization processes.

• Understanding of GS1 compliance.

• Project Management experience.

• Experience with Clinical Evaluation compilation to current MEDDEV guidance and Risk Management implementation to medical device standard ISO 14971.

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You will be rewarded with a great salary and benefits, and the onward opportunity to develop your career. Our client is currently shortlisting for interview, so please apply at your soonest convenience.