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Regulatory Affairs Manager

Vicon Motion Systems Limited

United Kingdom

On-site

GBP 50,000 - 70,000

Full time

14 days ago

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Job summary

A leading technology company in the UK seeks a Regulatory Affairs Manager to oversee regulatory clearances in global markets. This role requires 5+ years of compliance experience and a strong understanding of regulatory requirements for medical devices. The successful candidate will manage submissions, interact with authorities, and prepare technical documentation. Offers competitive salary and benefits including pension and private medical 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 of experience in a compliance role.
Strong understanding of applicable regulatory requirements.

Responsibilities

Manage regulatory clearances in global markets.
Plan medical device regulatory submission activities.
Interact with authorities for license applications.

Skills

Experience with EU MDR transition

Understanding of EU MDD and EU MDR transition

Knowledge of US medical device legislation

Familiarity with electromechanical medical devices

Proficient in MS Office applications

Exceptional written and verbal communication skills

Regulatory Affairs Manager

Department: Vicon Quality & Regulatory Compliance

Location: Yarnton, Oxfordshire, United Kingdom

We are looking for a Regulatory Affairs Manager to join our Quality and Regulatory Compliance team in Oxford, England.

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.

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.

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