The Regulatory Manager (RM) develops and implements global regulatory strategies for Acumed’s orthopedic implants from development through marketing approval
Job Summary
The Regulatory Manager (RM) develops and implements global regulatory strategies for Acumed’s orthopedic implants from development through marketing approval.
Responsibilities include managing systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the FDA regulatory submissions process.
Develop and train staff to ensure appropriate skills/behaviors are present to achieve strategic objectives.
Matching Summary
The Regulatory Manager (RM) 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
product development process
Six Sigma quality concepts
Nice-to-have
positive impact on the world
diverse learning opportunities
empowered to be their best
Lean Manufacturing concepts
Key Requirements
Bachelor’s degree in life sciences, engineering or related field
Six to 8 years of experience in Regulatory Affairs
prior leadership/management experience
Regulatory Affairs Certification preferred
Experience in implantable medical device manufacturing
Extensive knowledge of cGMP, FDP QSR CFR 820, MDR, ISO 9001, 9002, 13485, CE