Implantable medical device manufacturing knowledge
Fda submission process management
The Regulatory Manager will develop and implement global regulatory strategies for Acumed's orthopedic implants from development through marketing approval
Job Summary
The Regulatory Manager will develop and implement global regulatory strategies for Acumed's orthopedic implants from development through marketing approval.
As part of Marmon Holdings backed by Berkshire Hathaway, the role offers diverse learning opportunities and a culture where everyone is empowered to be their best.
The position requires managing systems for assembly, distribution, and tracking of information pertinent to the regulatory process, including authoring electronic submissions.
Matching Summary
The Regulatory Manager will develop and implement global regulatory strategies for Acumed's orthopedic implants from development through marketing approval.
Skills & Requirements
Must-have
Regulatory Affairs leadership experience
Implantable medical device manufacturing knowledge
FDA submission process management
cGMP and ISO 13485 compliance expertise
Global product registration strategy
Nice-to-have
Six Sigma quality concepts implementation
Lean Manufacturing familiarity
SAP ERP system proficiency
Strong team training and development skills
Strategic planning and budget management
Key Requirements
Bachelor's degree in life sciences or engineering
6 to 8 years of Regulatory Affairs experience
Prior leadership/management experience preferred
Experience with implantable medical devices required