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Senior Regulatory Affairs Associate

  • Location

    North Yorkshire

  • Salary

    Negotiable

  • Sector

    Compliance

  • Job Ref

    88277

  • Contact

    Will Godfrey

  • Published

    21 Tage her

Übersicht

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.

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.

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.

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.