Implantable medical device manufacturing knowledge
Fda submission process management
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.
This role involves managing departmental projects, creating labeling, interacting with governmental agencies like the FDA, and directing department employees.
Candidates must have extensive knowledge of cGMP, MDR, ISO 9001/13485, and CE standards to ensure compliance with international regulations.
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
6-8 years Regulatory Affairs experience
Implantable medical device manufacturing knowledge
FDA submission process management
cGMP and ISO 13485 standards expertise
Global regulatory strategy implementation
Nice-to-have
Six Sigma quality concepts application
Lean Manufacturing familiarity
SAP ERP system proficiency
Leadership and team training skills
Budget development and management
Key Requirements
Bachelor's degree in life sciences or engineering required
Master's degree preferred
Regulatory Affairs Certification preferred
Prior leadership experience in regulatory environment preferred