Regulatory Affairs Manager

linkup; Oxford; On-site; GBP 45,000 - 65,000; Full time

Job summary

A company in the medical device sector is seeking a Regulatory Affairs Manager in Oxford, UK. The role includes managing regulatory clearances globally and ensuring compliance with EU and US regulations. Candidates should have at least 5 years in a compliance role with significant knowledge of EU MDR and US medical device legislation. Strong communication skills and experience with electromechanical devices are essential. This position offers the chance to contribute to strategic regulatory direction and engage with various teams.

Qualifications

• 5 years of experience in a compliance role with a strong understanding of regulatory requirements.
• Experience with EU MDR transition and Technical File submission for Class IIa devices.
• Familiarity with regulatory requirements of non-medical devices, including EMC directive.

Responsibilities

• Manage new and existing regulatory clearances in global markets.
• Interact with authorities to support Technical File reviews and license applications.
• Contribute to Post Market Surveillance activities.

Skills

Regulatory compliance

EU MDR transition

Strong communication skills

Experience with electromechanical devices

Tools

MS Office

Adobe Acrobat

Job description

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.