Regulatory Affairs Team Leader

Austin Vita are delighted to be offering a fully remote, permanent, job opportunity for an experienced Medical Device Regulatory Affairs professional to join a well established Regulatory Group as a Team Leader working on Class III Devices for a global manufacturer.
Responsibiliites:
Preparation and review of regulatory documentation and submissions for product approval.
Development of regulatory plans/strategies for new products and changes to existing products.
Participation in Design Control, Risk Management and Post Market Surveillance activities.
Production and review of design dossiers, technical files and change assessments.
Review and preparation of regulatory paperwork in accordance with International standards and new regulations.
Review of product packaging, labelling, IFUs and marketing literature for compliance with specific country regulations.
Facilitate compliance with Vigilance System.
Provide regulatory input to functional groups as required.
Participate in review of RA procedures.
Review and approval of validation, protocols and reports.
Mentorship of RA Associates
For immediate consideration please forward your most up to date CV
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.
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Austin Fraser International Ltd is registered in England: 14971372 Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU
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