The Regulatory Manager develops and implements global regulatory strategies for Acumed’s orthopedic implants from development through marketing approval
Job Summary
The Regulatory Manager develops and implements global regulatory strategies for Acumed’s orthopedic implants from development through marketing approval.
Responsibilities include managing systems for regulatory submissions, authoring electronic submissions, and managing international product registration.
The role requires a Bachelor's degree in life sciences, engineering or related field, 6-8 years of Regulatory Affairs experience, and extensive knowledge of cGMP, FDP QSR CFR 820, MDR, and ISO standards.
Matching Summary
The Regulatory Manager develops and implements global regulatory strategies for Acumed’s orthopedic implants from development through marketing approval.
Skills & Requirements
Must-have
global regulatory strategies
orthopedic implants
regulatory applications
governmental agencies interaction
Six Sigma quality concepts
Lean Manufacturing concepts
Nice-to-have
positive impact on the world
diverse learning opportunities
empowered to be their best
strategic plan alignment
Key Requirements
Bachelor's degree in life sciences, engineering or related field
6-8 years of experience in Regulatory Affairs
Prior leadership/management experience
Regulatory Affairs Certification preferred
Implantable medical device manufacturing experience
Extensive knowledge of cGMP, FDP QSR CFR 820, MDR, ISO 13485