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For Companies At a Glance
- Tasks: Manage regulatory clearances and ensure compliance for cutting-edge motion capture technology.
- Company: Join Vicon, an Academy Award®-winning leader in motion capture systems.
- Benefits: Enjoy a competitive salary, generous leave, and private medical insurance.
- Other info: Dynamic role with opportunities for career growth in a leading tech company.
- Why this job: Be at the forefront of technology and make a real impact in innovative industries.
- Qualifications: 5+ years in regulatory compliance with strong knowledge of EU and US medical device regulations.
The predicted salary is between 36000 - 60000 £ per year.
Department: Vicon Quality & Regulatory Compliance
Location: Yarnton, Oxfordshire
Are you interested in working on products at the very cutting edge of technology? Want to join Vicon, an Academy Award®-winning company, and the world’s largest supplier of precision motion capture and tracking systems? Vicon is the world leader in motion capture technology, developing high performance software and hardware products for the entertainment, engineering and life science industries. Vicon products are used in major feature films, games, and commercials, and are a crucial measurement tool for biomechanics, robotics, and cutting‑edge science. Vicon is a subsidiary of Oxford Metrics Plc.
We are looking for a Regulatory Affairs Manager to join our Quality and Regulatory Compliance team in Oxford, England.
Key Responsibilities
- Manage new and existing regulatory clearances in global markets, including the EU, UK, USA, and other regions through support of a distribution network.
- Plan and achieve medical device regulatory submission activities including new market applications, registrations, and renewals.
- Act as an ambassador for Vicon in all aspects of the regulatory process, interacting with applicable authorities and auditors to support Technical File reviews, license applications, and surveillance audits.
- Write, review and collate applicable technical documentation, supporting development teams and authors to create project evidence that can achieve regulatory compliance.
- Contribute to Post Market Surveillance activities, summarising applicable data and authoring reports.
- Engage with distributors and in‑country representatives in relation to medical device clearance and renewal activities, ensuring all applicable obligations on the local representative and on Vicon as manufacturer have been met.
- Guide the strategic direction of future regulatory clearances in coordination with Sales and Product teams.
Required Skills, Knowledge and Expertise
The right candidate will have relevant industry experience and have worked for 5+ years in a compliance role with strong understanding of applicable regulatory requirements.
Essential Skills
- Experience with EU MDR transition and Technical File submission for Class IIa devices, as well as experience following guidance from MDCG and other sources.
- Strong understanding of EU MDD and EU MDR transition requirements for legacy devices.
- Experience with US medical device legislation and applicable guidance from the FDA.
- Familiarity with electromechanical medical devices, including devices that include software.
- Familiarity with regulatory requirements of non‑medical devices such as low‑voltage and EMC directives, where Vicon technology is sold to entertainment and engineering customers.
- Proficient use of MS Office applications and Adobe Acrobat.
- Exceptional written and verbal communication skills.
Desirable Skills
- Experience with MDSAP and medical device legislation of participating countries.
- Familiarity within the field of biomechanics, gait analysis, measurement devices or medical imaging is advantageous, but not necessary.
Benefits
- Competitive salary
- 10 % Company Pension
- 25 days Annual Leave + Bank Holidays
- Life Cover
- Private Medical with Optical / Dental Insurance
- Permanent Health Insurance
- Cycle to work scheme
- Free On‑site Parking
Seniority level: Executive
Employment type: Full‑time
Job function: Legal
Industries: Technology, Information and Internet
Regulatory Affairs Manager in Yarnton employer: Vicon
Contact Detail:
Vicon Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager in Yarnton
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend relevant events, and connect with professionals 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 Vicon and understanding their products and values. We want to see your passion for motion capture technology and how you can contribute to our team. Show us you’re not just another candidate!
✨Tip Number 3
Practice your responses to common interview questions, especially those related to regulatory affairs. We recommend doing mock interviews with friends or using online resources to boost your confidence and refine your answers.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who take the initiative to engage directly with us.
We think you need these skills to ace Regulatory Affairs Manager in Yarnton
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your relevant experience, especially in compliance and regulatory submissions. We want to see how your background aligns with what we do at Vicon!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how you can contribute to our team. Be sure to mention any specific experiences that relate to the key responsibilities outlined in the job description.
Showcase Your Communication Skills: Since exceptional written communication is essential for this role, make sure your application is clear and concise. We love well-structured documents, so pay attention to grammar and formatting to make a great impression!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining the Vicon family!
How to prepare for a job interview at Vicon
✨Know Your Regulations
Make sure you brush up on the latest EU MDR and US medical device legislation. Being able to discuss specific regulations and how they apply to Vicon's products will show that you're not just familiar with the industry, but that you’re ready to hit the ground running.
✨Showcase Your Experience
Prepare to share concrete examples from your past roles where you've successfully managed regulatory clearances or submissions. Highlight any experience with Technical File submissions for Class IIa devices, as this will resonate well with the interviewers.
✨Communicate Clearly
Since exceptional communication skills are essential for this role, practice articulating complex regulatory concepts in a straightforward manner. This will demonstrate your ability to act as an ambassador for Vicon and effectively interact with authorities and auditors.
✨Engage with the Team
Research Vicon’s products and their applications in various industries. During the interview, express your enthusiasm for collaborating with the Sales and Product teams to guide future regulatory clearances. This shows that you’re not just focused on compliance, but also on contributing to the company’s strategic goals.