Regulatory Affairs Manager

Regulatory Affairs Manager - Inside IR35 (6-12 Months)

LennTech are supporting a medical device UK based client whom are seeking to hire a Regulatory Affairs Consultant for an initial 6 month contract. This role is classed as Inside IR35 and will be remote based. UK candidates is preference for possible ad hoc onsite visits.

Needs to be someone immediately available to start within the next week.

KEY REQUIREMENTS

• Field expert in the areas below. Someone who can hit the ground running and take on the project and accountability as the group lead
• 510k submissions experience
• Lead or support key regulatory projects, including EUDAMED implementation, QSMR, UKCA compliance, and development devices
• Experience of working with regulatory bodies
• MDSAP - Preferential
• Previous country experience working with US, Canada, Australia
• MDR experience

EDUCATION & EXPERIENCE

• Significant experience in medical device regulatory affairs, including industry and/or regulatory agency/notified body experience.
• Strong understanding and ability to interpret medical device regulations and guidelines, including CFRs, MDD, ISO 13485, EN 60601-1, EN 14971, and EU MDR.