Regulatory Director - Complex Software/electronic medical devices

Regulatory Director - Complex Software/electronic medical devices Regulatory Affairs Director – complex Software/electronic medical devicesLondonOur client is a very successful medical device company with high-end, market-leading, active, medical device products sold globally. They invest heavily in their growing R&D division, offering excellent career enhancement and progression opportunities.Due to continued growth and investment, they have created a new position for a Regulatory Affairs Director to be based in their North London facilities.Our client has an established regulatory and quality division, this newly created role will report to the VP of Regulatory Affairs & Quality with responsibilities for managing the existing regulatory affairs managers and regulatory affairs staff.This is a fantastic opportunity to join a progressive medical device company with leading active (software / electronic driven), high-value, medical device products.This is an exclusive assignment for Indo Professionals – please apply today or contact Josh Craven for further details. 01256 597 800 / ##### Position:RA Director / Regulatory Affairs Director – Med TechLocation:North LondonJob role:This Regulatory Affairs Director role reports to the VP of RA/QA with the primary goal of supporting the international registration program with the new products they have coming to market.This is very much a hands-on role with a team leadership mix – our client needs someone who can lead from the front, taking an active role in assisting in the execution of submissions for complex medical device submissions in China, Russia, Japan, EU, US, Canada, Latin America and other markets.In order to fulfil this RA Director role, there is a requirement for overseas travel to meet regulatory authorities and local agents, to develop and execute strategy, to supervise testing (EMC or performance) and to negotiate with the relevant authorities.Our client is looking for a hands-on Regulatory Affairs Manager or Director with experience of getting active medical devices to market in multiple territories globally. To fully support product integration, our client also requires someone with an understanding of medical device testing e.g. EMC, performance, electrical safety.Further experience, skills, qualifications required include;- Degree level education within a relevant science / engineering discipline- Proven experience within a team management role – ideally 2 or more years, including leading local and international teams of at least 2 people- Experience with active medical devices (software / electronic, IEC 60601 IEC 62304) - Solid experience within medical device regulatory affairs- Direct experience of device testing- Experience of interacting with regulatory bodies such as notified body- Proven experience of successful submission of complex Class IIb / III active medical devices in China or Russia – essential- Experience with liaising with legal counsel, regulatory bodies and agencies- Experience in Clinical Literature Evaluation (CER)- Strong interpersonal skills including excellent communication, presentation and influencing skillsJob reference:J10022Indo Professionals is a specialist staffing business dedicated to the medical technology market. We focus solely on placing professionals within quality, regulatory and clinical research teams. If you are actively or passively looking for your next career challenge and wish to partner with a true recruitment specialist within your field, please contact us today.
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