Associate Director, Regulatory Affairs – Europe
Lifelancer
MCRA is a leading medical device advisory firm and clinical research organization (CRO). MCRA’s value contribution rests within its industry experience at integrating five business value creatorsregulatory, clinical research, reimbursement, healthcare compliance, and quality assuranceto provide a dynamic, market-leading effort from concept to commercialization. MCRA’s integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1100 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.
OverviewThe Manager, Regulatory Affairs is a critical team member supporting regulatory strategy and submissions for the firms clientele. The primary roles and responsibilities include writing, reviewing, and managing regulatory submissions, development of overall regulatory strategy, and communicating with regulatory bodies and clients with support of senior MCRA staff, as needed. The projects may be for companies in MCRA therapeutic areas, other MCRA areas of regulatory and scientific expertise, and/or other growing therapeutic concentrations of MCRA.This open position is a remote-based employee located in Europe with expertise in EU MDR and UK MDR. Experience reviewing submissions as part of Notified Body staff or experience with the application process through to CE Mark/UKCA Mark is highly preferred. Experience with PRRC or Legal Representative / Authorized Representative activities is advantageous. The ability to manage and own projects with little oversight is expected.Responsibilities and Duties
Required Knowledge, Skills, and Experience
Supervisory Responsibilities
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London
Thu, 14 Nov 2024 23:37:18 GMT
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