Regulatory Affairs Manager

Company: CV-Library
Job type: Full-time
Salary:
80,000 - 100,000 GBP/Year

Regulatory Affairs Manager – Medical devices – Cambridgeshire- £80-100K

A client of nGenium who develop medical devices are looking for a medical regulatory affairs manager.

Objective / Purpose of Role

To manage the Regulatory Affairs function of the Operations department, carrying out a range of tasks supporting the fulfilment of responsibilities of the Marketing Authorisation Holder for the product portfolio, working with Quality Assurance, Medical Affairs, and external contractors.

Key Activities / Key Responsibilities:

• Manage the preparation and review of regulatory applications such as variations, change of ownership applications, renewals in the UK and US Regulatory compliance tracking
• Regulatory filing and administration
• Communication of regulatory changes internally and externally
• Generation, review and implementation of Product Information (Summary of Product Characteristics, leaflets and labelling)
• Review and processing of certificates of analysis for received product batches
• Review of stability reports, annual Product Quality Reviews, SOPs, other technical documents and change controls
• Review and support updates to product Artwork
• Handling Product Quality Complaints
• Assist in the production and review of design dossiers technical files, and Product Approval Certificates.
• Preparation of regulatory submission for product approvals.
• Preparation of Custom Made device, Special Products paperwork and change assessments.
• Participate in Design Control, Risk Management, Post Market Surveillance and document changes

Qualifications & Experience :-

• BSc Hons Degree or equivalent.
• Regulatory experience within a medical device environment is essential

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