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- Tasks: Lead regulatory processes for innovative medical devices and ensure compliance across multiple regions.
- Company: Join a world leader in glucose monitoring with a diverse global network.
- Benefits: Competitive salary, flexible benefits, private healthcare, and career growth opportunities.
- Other info: Dynamic office environment with extensive opportunities for personal and professional development.
- Why this job: Make a real impact in healthcare by driving regulatory strategies for life-changing technologies.
- Qualifications: Degree in a scientific field and 8+ years in regulatory affairs or related experience.
The predicted salary is between 90000 - 90000 £ per year.
This is an excellent opportunity to join a leading medical device manufacturing company that is the world leader in Glucose Monitoring. Their product portfolio develops and manufactures glucose monitoring systems for use in both home and hospital settings.
With a diverse, global network serving customers in more than 160 countries, the organisation creates new solutions across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, the business is advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The business currently has one open position as Regulatory Affairs Manager who will be responsible for planning, creating, and implementing solutions for regulatory registration and release of products for distribution into specific geographies.
Key Responsibilities:- Lead processes and team involved with obtaining and maintaining product registration, release authorization, and release of products to specified geographies.
- Authoring and updating technical files.
- Leading all activities related to class II and class III medical devices including SaMD.
- Driving new registrations in the UK, EU, Middle East, and Pakistan regions.
- Drive regulatory strategies including working cross-functionally with other departments to ensure the right strategy is defined.
- Provide training and mentoring to junior colleagues with the scope to get into line management depending on the individual's preference.
- Interact with notified bodies and keep well-versed in global regulations.
- University degree in a scientific subject, such as Biomedical science, Chemistry, Pharmacy, Engineering, or equivalent experience.
- Experience working within the requirements of ISO 13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC).
- Minimum of 8 years post-qualification experience in regulatory affairs, quality or R&D in the medical device and/or pharmaceutical industry in product registration, medical device file, and/or technical compliance activities.
Due to the organisation's rapid growth, there is extensive opportunity to grow and develop within the company. In addition to a competitive salary, the organisation offers a highly attractive benefits package that includes a defined-contribution pension scheme, a share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme that you can tailor to your own requirements.
This role is 100% on site, so you must be able to commit to this.
Regulatory Affairs Manager in Witney employer: Cpl Healthcare
Contact Detail:
Cpl Healthcare Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager in Witney
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field, especially those working with medical devices. Attend industry events or webinars to make connections and learn about potential job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and the Medical Devices Directive. Be ready to discuss how your experience aligns with the responsibilities of the Regulatory Affairs Manager role.
✨Tip Number 3
Showcase your leadership skills! If you have experience mentoring junior colleagues, be sure to highlight this during interviews. Companies love candidates who can lead and develop others.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals to join our team in making a difference in healthcare.
We think you need these skills to ace Regulatory Affairs Manager in Witney
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your experience with medical devices and regulatory compliance, especially with ISO 13485 and relevant directives. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs in the medical device sector. Share specific examples of your achievements and how they relate to the responsibilities outlined in the job description.
Showcase Your Team Leadership Skills: Since this role involves mentoring junior colleagues, be sure to mention any leadership or training experiences you've had. We love seeing candidates who can inspire and guide others, so don’t hold back on those stories!
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 submit all your documents in one go. Plus, it shows us you’re serious about joining our team!
How to prepare for a job interview at Cpl Healthcare
✨Know Your Regulations
Make sure you brush up on the key regulations relevant to medical devices, especially ISO 13485 and the Medical Devices Directive. Being able to discuss these confidently will show that you’re not just familiar with the requirements but also understand their implications in real-world scenarios.
✨Showcase Your Experience
Prepare specific examples from your past roles where you successfully navigated regulatory challenges or led a team through product registrations. This will help demonstrate your hands-on experience and problem-solving skills, which are crucial for the Regulatory Affairs Manager position.
✨Cross-Functional Collaboration
Since this role involves working with various departments, think of instances where you’ve collaborated cross-functionally. Be ready to discuss how you’ve driven regulatory strategies while ensuring alignment with other teams, as this will highlight your teamwork and leadership abilities.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s current projects or future regulatory challenges they might face. This shows your genuine interest in the role and helps you gauge if the company culture aligns with your career goals.