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Global Regulatory Affairs Manager II

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

United States

Offer summary

Qualifications:

Experience in medical devices, MDR STeD file authoring expertise, Regulatory strategy development experience, Excellent communication and project management skills, Minimum of BS in related scientific discipline.

Key responsabilities:

Strategic leadership on EU MDR projects
Lead teams for MDR STeD file development
Coordinate cross-functional teams for compliance
Schedule and lead project review meetings

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:

This position will independently provide tactical and strategic leadership on complex EU MDR projects within the Global Regulatory Affairs organization by actively compiling and authoring EU MDR-compliant STeD files.
Independently lead development, remediation, planning, and authoring of EU MDR STeD files for Class IIa and IIb products.
Coordinate and lead cross-functional teams aimed at remediating MDD STeD files into MDR-compliant files, including Manufacturing, R&D, Pre-Clinical Safety, and Quality.
Lead project review meetings for management's oversight on progress and risks.

Requirements:

Experience in a medical device required.
Experience in MDR STeD file authoring required.
Develop and implement regulatory strategy aligned with business strategy.
Excellent communication and project management skills.
Preferred Skills/Qualification:
Strong technical writing skills.
Strong project management skills.
B.S. required in related scientific discipline with a minimum of 5 years of regulatory experience.
MS degree and 3 years of regulatory experience.
PhD and 1 years of regulatory experience.