Regulatory Affairs Manager

Regulatory Affairs Manager linkup•Oxford, UK

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 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. 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. 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.

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