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 manage the full lifecycle of regulatory submissions including 510(k), PMA, and MDR Technical Files while overseeing product registration globally.
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
Global regulatory strategy implementation
FDA submission authorship and management
cGMP and ISO 13485 compliance knowledge
Implantable medical device manufacturing experience
Team leadership and performance management
Nice-to-have
Six Sigma quality concepts implementation
Lean Manufacturing familiarity
SAP ERP system experience
Master's degree in life sciences or engineering
Regulatory Affairs Certification preferred
Key Requirements
Bachelor's degree in life sciences or engineering required
6-8 years Regulatory Affairs experience required
Prior leadership/management experience preferred
Experience in implantable medical device manufacturing required
Knowledge of cGMP, QSR CFR 820, MDR, ISO standards