Role OverviewThe Regulatory Affairs Specialist II will execute regulatory activities to support currently marketed devices and new product development in the DePuy Synthes Joint Reconstruction and VELYS Digital Surgery line of products.
What You Will Do
Responsibilities include preparing regulatory documentation, reviewing engineering changes, and providing product information and regulatory guidance to project teams.
Why It Might Be a Fit
The ideal candidate will have excellent written and oral communications skills, ability to handle multiple tasks, and knowledge of medical devices, with preference for orthopaedics, capital equipment, robotics, and software.
Requirements
- BA/BS degree with minimum 2 years Regulatory Affairs experience in medical devices
- Experience with US FDA Regulations and European Medical Device Regulations (and previous Medical Device Directives) required
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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