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- Tasks: Lead regulatory strategies and ensure compliance for innovative medical devices.
- Company: Join a pioneering medical devices company focused on advanced wound care solutions.
- Benefits: Enjoy competitive salary, hybrid working, 33 days holiday, and a contributory pension scheme.
- Why this job: Make a real impact in healthcare while working on global regulatory strategies.
- Qualifications: Degree in Regulatory Affairs, Science, or Engineering; strong knowledge of medical device regulations required.
- Other info: Be part of a team that values innovation and continuous improvement in compliance.
The predicted salary is between 36000 - 60000 £ per year.
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 are not just a medical devices manufacturer; we are 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!
RAQ Manager - Regulatory Affairs & Quality (New Products) employer: SFM
Contact Detail:
SFM Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land RAQ Manager - Regulatory Affairs & Quality (New Products)
✨Tip Number 1
Familiarise yourself with the latest regulations in the medical device sector, particularly EU MDR 2017/745 and 21 CFR 820. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in regulatory affairs and quality management. Attend industry conferences or webinars to connect with others in the field. This can provide valuable insights and may even lead to referrals for the RAQ Manager position.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully managed regulatory submissions or compliance strategies in the past. Highlighting your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Showcase your ability to work collaboratively across functions. Be ready to share instances where you've effectively communicated with cross-functional teams or regulatory authorities, as this is crucial for the role at StudySmarter.
We think you need these skills to ace RAQ Manager - Regulatory Affairs & Quality (New Products)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs and quality management. Emphasise your knowledge of Medical Device Regulations and any specific projects that align with the role.
Craft a Compelling Cover Letter: In your cover letter, explain why you are passionate about regulatory affairs in the medical devices sector. Mention specific examples of how your skills and experiences make you the ideal candidate for the RAQ Manager position.
Highlight Key Achievements: When detailing your previous roles, focus on key achievements related to regulatory submissions and compliance. Use metrics where possible to demonstrate your impact, such as successful product launches or improved compliance rates.
Showcase Communication Skills: Since the role requires collaboration across functions, highlight your communication skills. Provide examples of how you've effectively worked with teams or regulatory authorities to navigate compliance challenges.
How to prepare for a job interview at SFM
✨Understand Regulatory Frameworks
Familiarise yourself with the key regulations such as EU MDR 2017/745 and 21 CFR 820. Be prepared to discuss how these regulations impact product development and compliance strategies.
✨Showcase Your Leadership Skills
As an RAQ Manager, you'll be leading regulatory strategies. Highlight your experience in managing teams and projects, and provide examples of how you've successfully navigated compliance challenges in the past.
✨Demonstrate Continuous Improvement Mindset
Discuss your approach to staying updated on global regulatory changes and how you implement continuous improvement in compliance processes. This shows your proactive attitude towards regulatory affairs.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about past experiences where you had to make critical decisions regarding regulatory submissions or compliance issues.
