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, developing dossiers for international registration, and overseeing staff in preparing submissions to regulatory agencies.
The company is committed to making a positive impact on the world, providing diverse learning opportunities, and fostering an empowered culture.
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
FDA regulatory submissions
international product registration
cGMP, FDP QSR CFR 820
ISO 13485
MDR, CE
Nice-to-have
Six Sigma quality concepts
Lean Manufacturing concepts
ERP systems, SAP preferred
leadership at every level
positive impact on the world
Key Requirements
Bachelor's degree in life sciences, engineering or related field
6-8 years of experience in Regulatory Affairs
Prior leadership/management experience preferred
Regulatory Affairs Certification preferred
Experience in implantable medical device manufacturing