Regulatory Affairs And Quality Specialist - Scientific Equipment

FRENCH SELECTION UK
Regulatory Affairs & Quality Specialist (Scientific Equipment)
Quality manager, R&D, Research & development, Scientific, Engineering, Regulatory, Pharmacy, Legal, Quality,
Regulatory Affairs, ISO 13485:2016, ISO 14971:2019, QSR, IVDD and IVDR, QRA, Regulatory & Quality Coordinator, RA & QA Specialist, Quality manager, Regulatory Affairs Specialist, Regulatory Compliance officer
Salary: circa £45,000 pa + Benefits
Location: Cambridge, Cambridgeshire
Commutable / Relocation possible from New Market, Bury St Edmunds, Middleton, Peterborough, Brickhill, Hitchin, Bedford, Haverhill, Northampton, Bury St Edmunds, Ipswich, Norwich, Colchester, Chelmsford, Luton, London, Leicester, Manchester
Ref: 726CA
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Please visit the French Selection UK website, vacancies section, search job reference: 726CA
Applications submitted on our website will come to us in the correct format, which means they will be processed faster & more efficiently by our team of consultants.
The Company:
A leading manufacturer of specific scientific instruments for a wide range of applications in the clinical, life-science & industrial markets.

Main Duties:
Responsible for supporting the initiation, achievement and maintenance of product registrations, timely undertaking of post market surveillance and vigilance activities. Contribute to maintaining regulatory compliance certifications and driving continuous improvement activities.

The Role:
- Provide supporting quality and regulatory expertise to the organisation.
- Track regulatory changes, future developments and analyse the impact to both system & products.
- Support internal training activities & provide interpretation of regulatory requirements across the global territories
- Prepare of first time ready technical documentation for submissions / responses to Notified Body & relevant Competent Authorities.
- Support review & approval of product labelling & promotional material / regulatory compliance responsibility for post market activities
- Provide support to distribution partners and ensure that appropriate vigilance processes and timelines are met.
- Undertake impact assessments for changes to documentation, processes and system raised both internally and by contract manufacturers.
- Support the management of internal and external third-party audits.
- Analyse product and system data. Prepare relevant reports.
- Actively participate in process, product, and system efforts to advance our continuous improvement culture.
- Build strong relationships with internal and external customers to ensure regulatory compliance and audit readiness.

The Candidate:
- Degree with scientific/engineering/regulatory/pharmacy/legal/quality competency
- Ideally 1-2 years in R&D (for D&D knowledge) and 1-2 QARA or RA
- Open to candidates still early in RA career with a desire to continue to learn
- Knowledge and/ or experience working to ISO 13485:2016, ISO 14971:2019, QSR, IVDD and IVDR
- Good understanding/ knowledge of where to find applicable guidance documents
- Comfortable in a SME environment & working withing a very small combined QA and RA team

The Salary: Circa £45,000 pa + Benefits
French Selection, leading UK-based consultancy specialising in the recruitment of bilingual and multilingual professionals for international business (industries and services). We are the leading recruitment consultancy for German, French, Italian and Spanish speaking positions. Also recruiting for positions with other languages such as Dutch, Polish, Portuguese, Scandinavian languages, Mandarin, Japanese and Arabic.