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- Tasks: Lead Quality Assurance and Regulatory Affairs for innovative medical technology products.
- Company: Join BD, a global leader in medical technology with a purpose-driven mission.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Why this job: Make a real impact on health by ensuring product compliance and quality.
- Qualifications: Degree in Life Science or Engineering; strong regulatory affairs experience required.
- Other info: Dynamic role with leadership opportunities and a focus on continuous improvement.
The predicted salary is between 77100 - 117600 £ per year.
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
The Senior Manager QRA UKI and Nordics leads the Quality Assurance and Regulatory Affairs function across the region, ensuring full compliance with internal standards and external regulatory requirements. The role drives operational excellence, maintains ISO certifications, and safeguards BD’s responsibilities for products placed on the market. It includes regional representation towards Competent Authorities, guidance on local regulatory expectations, and contribution to broader EMEA QRA initiatives. The position also provides strategic partnership to commercial leadership teams and ensures strong alignment between local operations, distributors, and regional QRA direction. A central element of the role is building, developing and mentoring a high‑performing QRA team while promoting a culture of accountability, collaboration and continuous improvement.
Main Responsibilities
- Alignment between UK, Ireland and Nordics operations, distributor activities and EMEA QRA strategy
- Implementation and maintenance of the Quality Management System
- Maintenance of ISO certifications for relevant locations within scope
- Assurance of regulatory compliance for the portfolio, including registrations, AdProm, audits, pharma requirements and distributor oversight
- Representation of BD in interactions with Competent Authorities and management of regulatory submissions and communications
- Monitoring and interpretation of current and emerging regulations and recommendation of updates to systems, policies and procedures
- Oversight of accurate and consistent regulatory records and mitigation of compliance risks to secure product supply
- Leadership of the QRA team, including recruitment, development and strengthening of regulatory capabilities
About You
- Degree in Life Science, Engineering or Physical Science; an advanced degree or MBA is a plus
- Strong experience in Regulatory Affairs management with proven expertise in compliance and regulatory frameworks
- Quality assurance experience is highly beneficial, particularly in supporting compliance and quality systems
- Solid knowledge of MDR, IVDR, ISO 13485:2016, ISO 9001:2015, with practical experience in UK regulatory environment
- Familiarity with local pharmaceutical regulations is a plus, not a core requirement
- Demonstrated first experience in a leadership role, with the ability to guide cross‑functional initiatives and drive results
- Capable of building trust and strengthening relationships from the ground up, representing BD confidently towards authorities, and driving collaboration across internal and external partners
Primary Work Location: Winnersh, England, United Kingdom
Salary Range: £77,100.00 - £117,600.00 GBP Annual
Senior Manager, Quality Assurance & Regulatory Affairs- UKI & Nordics in Winnersh employer: BD
Contact Detail:
BD Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager, Quality Assurance & Regulatory Affairs- UKI & Nordics in Winnersh
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. We want you to show how your experience aligns with their mission. Practise common interview questions and think about how you can demonstrate your leadership skills and regulatory expertise.
✨Tip Number 3
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We suggest mentioning something specific from your conversation to show you were engaged and interested.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we’re always looking for passionate individuals who want to make a difference in the world of health.
We think you need these skills to ace Senior Manager, Quality Assurance & Regulatory Affairs- UKI & Nordics in Winnersh
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that align with the Senior Manager role. Highlight your expertise in Quality Assurance and Regulatory Affairs, especially in relation to ISO standards and compliance.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to tell us why you're passionate about advancing health and how your leadership experience can drive our QRA team to success. Be genuine and let your personality come through.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use quantifiable results to demonstrate how you've improved compliance or operational excellence in previous roles. We love seeing how you’ve made a difference!
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to keep track of your application status. Plus, we can’t wait to see what you bring to the table!
How to prepare for a job interview at BD
✨Know Your Regulations
Make sure you brush up on the latest regulations relevant to the role, especially MDR and IVDR. Being able to discuss these confidently will show that you’re not just familiar with the compliance landscape but also ready to lead in it.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams or projects in the past. Highlight your ability to build trust and foster collaboration, as this is crucial for the Senior Manager role. Think about specific challenges you faced and how you overcame them.
✨Align with Company Values
Understand BD’s purpose of advancing health and think about how your personal values align with this mission. Be ready to discuss how you can contribute to their goals and promote a culture of accountability and continuous improvement within the QRA team.
✨Prepare Questions for Them
Have insightful questions ready to ask your interviewers. This could be about their current QRA initiatives or how they envision the future of regulatory affairs at BD. It shows your genuine interest in the role and helps you assess if the company is the right fit for you.
