Regulatory Affairs Manager

Vicon Motion Systems Ltd.; Yarnton; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A leading technology firm in motion capture is seeking a Regulatory Affairs Manager to manage regulatory clearances globally. The role involves planning and executing submissions for medical devices and ensuring compliance with EU and US regulations. Candidates should have 5+ years in a compliance role with a strong understanding of applicable regulatory requirements. The position offers a hybrid work environment and a range of benefits including a competitive salary and health insurance.

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

Qualifications

• 5+ years in a compliance role with strong understanding of regulatory requirements.
• Experience with medical device legislation from the EU and USA.
• Familiarity with electromechanical medical devices preferred.

Responsibilities

• Manage regulatory clearances in global markets.
• Plan medical device regulatory submission activities.
• Support development teams to achieve regulatory compliance.

Skills

Experience with EU MDR transition and Technical File submission for Class IIa devices

Strong understanding of EU MDD and EU MDR transition requirements

Experience with US medical device legislation

Familiarity with electromechanical medical devices

Proficient use of MS Office applications and Adobe Acrobat

Exceptional written and verbal communication skills

Job description

Regulatory Affairs Manager

Department: Vicon Quality & Regulatory Compliance

Employment Type: Permanent - Full Time

Location: Yarnton, Oxfordshire

Reporting To: Adam Taylor

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

Reporting to the Head of Quality and Regulatory Compliance, the Regulatory Affairs Manager is responsible for managing new and existing regulatory clearances in global markets, including the EU, UK, USA, and globally 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. Support development teams and other authors to create project evidence that can achieve regulatory compliance. Contribute to Post Market Surveillance activities, including 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.

You will have opportunities to guide the strategic direction of the future regulatory clearances, in coordination with Sales and Product teams.

We offer a hybrid on‑site/home‑based working environment, with head office located in a major academic city. There is no expectation to be 'on call' outside core office hours.

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 applicable guidance documentation 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 documentation from FDA.
• Familiarity with electromechanical medical devices, including devices that include software.
• Familiarity with regulatory requirements of non‑medical devices, including for example, low voltage directive, EMC directive and equivalent global legislation, as applicable 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