Regulation Manager - Medical Device

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 activities

• 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).

Requirements:

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

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

• 3+ years of Managerial Experience.

• Demonstrable experience in successfully developing and managing regulatory submissions.

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

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

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

• Ability to work well under pressure.

• English - high proficiency - Must.