Regulatory Affairs Manager

Regulatory Affairs ManagerRead on to find out what you will need to succeed in this position, including skills, qualifications, and experience.Department: Vicon Quality & Regulatory ComplianceEmployment Type: Permanent - Full TimeLocation: Yarnton, OxfordshireReporting To: Adam TaylorDescriptionAre 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 ResponsibilitiesReporting 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 ExpertiseThe 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 SkillsExperience 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 SkillsExperience 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. xpwpeyx BenefitsCompetitive salary10% Company Pension25 days Annual Leave + Bank HolidaysLife CoverPrivate Medical with Optical / Dental InsurancePermanent Health InsuranceCycle to work scheme.Free On‑site Parking#J-18808-Ljbffr