Implantable medical device manufacturing knowledge
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 provides leadership in creating regulatory policies, managing departmental projects, and directing employees to ensure compliance with FDA and international agencies.
Candidates will oversee the authorship of electronic submissions and manage maintenance of establishment listings for the FDA, Health Canada, and EU MDD/MDR.
Matching Summary
The Regulatory Manager develops and implements global regulatory strategies for Acumed's orthopedic implants from development through marketing approval.
Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
Global regulatory strategy implementation
FDA submission management experience
Implantable medical device manufacturing knowledge
Nice-to-have
Six Sigma quality concepts application
Lean Manufacturing familiarity
SAP ERP system proficiency
Key Requirements
Bachelor's degree in life sciences or engineering
Six to eight years of Regulatory Affairs experience
Prior leadership or management experience preferred
Regulatory Affairs Certification preferred
Extensive knowledge of cGMP and ISO 13485 standards