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.
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.
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.
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.