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 assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the FDA regulatory submissions process.
The company is committed to making a positive impact on the world, providing diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.
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
Develop global regulatory strategies
Manage regulatory submissions
Create and review labeling
Interact with governmental agencies
Implement Six Sigma quality concepts
Nice-to-have
Positive impact on the world
Diverse learning opportunities
Empowered work culture
Familiarity with Lean Manufacturing
Key Requirements
Bachelor's degree in life sciences, engineering or related field
6-8 years in Regulatory Affairs
Prior leadership/management experience
Experience in implantable medical device manufacturing
Knowledge of cGMP, FDA QSR CFR 820, MDR, ISO 13485