Job Description

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 manufacture 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

About Vicon Motion Systems

Vicon is the world leader in Motion Capture, developing high performance software and innovative hardware products for the entertainment, engineering and medical industries. Vicon systems are a crucial tool for measurement and 3D tracking for cutting-edge science including biomechanics, robotics and virtual or augmented reality. Vicon products have been used in many major feature films, video games and commercials. We have offices in Yarnton, Denver, Los Angeles and Auckland.

Vicon Motion Systems Ltd is a subsidiary company of Oxford Metrics Plc.



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