Regulation Manager - Medical Device (Class III )

A leading Medical Device company is seeking an experienced Regulation Manager to manage a team of Class III regulatory projects managers.

Key duties

:• Manage a team of regulatory projects managers

.• Support global and regional regulatory activitie

s• Prepare and manage various submissions and correspondence to regulatory authorities ensuring adherence to national and international regulations and standards (e.g. FDA, Health Canada, European Union and Asia)

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Requirement

s:• Bachelor’s degree in a Science discipline – life science, biochemistry, pharmacy or chemistr

y.• 6+ years of regulatory affairs in medical device/pharmaceutical drug development, preferably 2-3 years CMC experienc

e.• 3+ years of Managerial Experienc

e.• Demonstrable experience in successfully developing and managing regulatory submission

s.• Prior experience with the preparation of CMC sections for regulatory submissions, as well as experience in registration of Device-Drug Combination Products (Class III) - Advantag

e.• Knowledgeable in FDA, EU, and/or Global regulatory submission processes is desirabl

e.• Exceptional organizational skills, ability to multi-task and be detail oriente

d.• Ability to work well under pressur

e.• English - high proficiency - Mus