Regulatory Affairs Manager

Vicon; Yarnton; On-site; GBP 60,000 - 75,000; Full time

Benefits offered by this job

Competitive salary

10% Company Pension

25 days Annual Leave

Private Medical Insurance

Cycle to work scheme

Free On-site Parking

Job summary

A leading technology firm in the United Kingdom is seeking a Regulatory Affairs Manager to oversee regulatory clearances in global markets. The ideal candidate will have over 5 years of compliance experience in the medical device sector and a strong knowledge of EU and FDA regulations. This role offers an opportunity to contribute directly to the regulatory strategy and ensure compliance across products in a cutting-edge technology environment.

Qualifications

• 5+ years in a compliance role required.
• Experience with EU MDR transition and technical submissions.
• Familiarity with software-based medical devices is a plus.

Responsibilities

• Manage regulatory clearances for global markets.
• Plan and execute medical device submission activities.
• Act as ambassador for the company with authorities.

Skills

Regulatory compliance experience

Strong communication skills

Understanding EU MDR and FDA regulations

Experience with medical devices

Proficient use of MS Office

Job description

Department: Vicon Quality & Regulatory Compliance

Location: Yarnton, Oxfordshire

Description

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

Additional Information

• Seniority level: Executive
• Employment type: Full‑time
• Job function: Legal
• Industries: Technology, Information and Internet