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Regulatory Manager

Vacancy Title: Regulatory Manager
Contract Type: Permanent
Location: Leeds, West Yorkshire
Industry:
Salary: Negotiable
REF: J901972_1565194924
Contact Name: Zoe Burgess
Contact Email: zoe.burgess@russell-taylor.co.uk
Vacancy Published: 11 days ago

Vacancy Description

Role: Regulatory Manager
Location: Leeds
Type: Permanent
Salary: DoE

My client are an established manufacturer of medical devices, striving for innovation & quality.

Role:
* Producing reporting schedules for regulatory actions
* Developing/maintaining QMS for product registrations (for UK & global markets)
* Leading distributor evaluation & approval
* Writing & preparation of technical documents for regulatory requirements
* Ensuring continuous improvement & compliance
* Ensuring strict adherence to correct labelling of medical device as per compliance
* Writing / managing / reviewing clinical evaluation reports
* Development / management of Post-Market Clinical Follow-Up projects
* Liaising as the primary contact in regulations for international distributors
* Providing support, dealing with enquiries / requests for international distributors

Candidate Requirements:
* Background in EU Medical Device Regulations (MDR), FDA Regulations (21 CFR 820), Canadian Medical Device Regulations, & other international regulations
* Understanding of ISO13485 & ISO9001
* Evidence of project management skills (including; Gantt charting, work breakdown structure, communication plan)
* Excellent communication skills
* Strong written & verbal command of the English language
* Evidence of leading & innovating in a cross-functional environment

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