Develops and implements global regulatory strategies for Acumed’s orthopedic implants from development through marketing approval
Job Summary
Develops and implements global regulatory strategies for Acumed’s orthopedic implants from development through marketing approval.
Provides regulatory leadership and ensures compliance with all regulatory applications including submissions, managing departmental projects, creating, and reviewing labeling, interacting with governmental agencies, and directing and managing department employees.
Develop and train staff to ensure appropriate skills/behaviors are present to achieve strategic objectives and perform annual performance reviews for direct reports.
Matching Summary
Develops and implements global regulatory strategies for Acumed’s orthopedic implants from development through marketing approval.
Skills & Requirements
Must-have
global regulatory strategies
orthopedic implants
FDA regulatory submissions process
international product registration
cGMP, FDP QSR CFR 820
ISO 13485, CE standards
Nice-to-have
positive impact on the world
diverse learning opportunities
empowered to be their best
Six Sigma quality concepts
Lean Manufacturing concepts
Key Requirements
Bachelor's degree in life sciences, engineering or related field
Six to 8 years of experience in Regulatory Affairs
prior leadership/management experience
Regulatory Affairs Certification preferred
implantable medical device manufacturing experience
Extensive knowledge of cGMP, FDP QSR CFR 820, MDR, ISO 9001, 9002, 13485, CE
Familiarity with Lean Manufacturing concepts
Knowledge and experience with ERP systems, SAP preferred