Regulatory Affairs & Quality Specialist (Scientific Equipment)

Cambridge

Ref: 726CA

Company Profile

A leading manufacturer of specific scientific instruments for a wide range of applications in the clinical, life-science & industrial markets.

Responsibilities

Regulatory Affairs & Quality Specialist (Scientific Equipment)
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


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

Candidate's Profile

- 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

Salary

Circa £45,000 pa + Benefits

Keywords

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

Status

Live


Salary

Circa 45,000 pa


Reference

726CA


Location

Cambridge


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