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RAQ Manager - Regulatory Affairs & Quality (New Products)
Location: Coventry, CV3 2RQ
Salary: Competitive (DOE)
Contract: Full-Time, Permanent
Why Join Us
Innovate in Healthcare - Be part of a forward-thinking medical devices company developing cutting-edge wound care solutions.
Make an Impact - Play a key role in ensuring regulatory compliance for life-changing medical products.
Global Reach - Work on regulatory strategies that impact markets across the UK, EU, USA, and beyond.
Perks & Benefits
Competitive salary
Contributory pension scheme
Hybrid/Flexible working
33 days holiday (including bank holidays)
Life cover & incapacity benefits
Cash Back Medical Scheme
About Us
We're not just a medical devices manufacturer - we're innovators in advanced wound care solutions. Our high-quality, cost-effective products improve patient care and wellbeing worldwide.
Your Mission
As RAQ Manager, you will lead the company's global regulatory submissions and compliance strategy. You'll ensure that our innovative medical devices meet the highest regulatory standards, supporting product development and market expansion.
Your Key Responsibilities
Lead regulatory strategies and act as the go-to expert for product development and design changes.
Take charge of regulatory submissions for key global markets (USA, EU, UK).
Manage the post-market surveillance and vigilance programs to ensure compliance.
Stay ahead of global regulatory changes and drive continuous improvement in compliance.
Deliver training programs to enhance regulatory awareness across the company.
Work closely with Regulatory Authorities and Notified Bodies to navigate compliance challenges.
What You'll Bring
Degree in Regulatory Affairs, Science, or Engineering (or equivalent).
Strong knowledge of Medical Device Regulations (EU MDR 2017/745, 21 CFR 820, UKCA).
Ability to analyse and interpret regulatory landscapes and drive effective strategies.
A team player with strong communication skills, ready to collaborate across functions.
Ready to Make an Impact
APPLY NOW! Send us your CV and cover letter explaining why you're the perfect fit.
Note: Due to high application volumes, only shortlisted candidates will be contacted. We reserve the right to close applications early.
No agencies, please!
