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
Vicon is an exceptional employer located in the vibrant community of Yarnton, Oxfordshire, offering a dynamic work culture that fosters innovation and collaboration. Employees benefit from comprehensive growth opportunities, including professional development and cross-functional teamwork, all while contributing to impactful advancements in life sciences and biomechanics. With a commitment to employee well-being and a focus on meaningful work, Vicon stands out as a rewarding place to build a career.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager in Yarnton
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Vicon looking for candidates who are engaged and informed.
We think you need these skills to ace Regulatory Affairs Manager in Yarnton
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Vicon. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Vicon
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Vicon’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
