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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
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.
Check us out on our websiteandLinkedIn for more roles.
We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Noticeor contact (url removed) Austin Fraser International Ltd is registered in England: (phone number removed) Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU
