Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist is responsible for regulatory activities to support new, modified, and currently marketed medical devices in the DePuy Joint Reconstruction portfolio. This includes preparing regulatory documentation for submission to regulatory authorities and reviewing and approving device labeling and product support information.

What You Will Do

Prepares regulatory documentation for DePuy devices, provides support in preparation of global registration activities, and reviews and approves changes with Product Lifecycle Management System to devices, design, packaging, and labeling.

Why It Might Be a Fit

The ideal candidate will have a minimum of 2 years of prior relevant regulatory affairs or experience in medical devices, with knowledge of U.S. FDA and EU Medical Device Regulations MDR (and previous MDD) and presiding guidance's and standards.

Requirements

• Minimum of 2 years plus prior relevant regulatory affairs or experience in medical devices
• A minimum of 2 years plus medical device industry experience or relevant medical device experience
• Knowledge or Familiarity of U.S. FDA and EU Medical Device Regulations MDR (and previous MDD) and presiding guidance's and standards a plus
• Knowledge of orthopedic implants a plus
• Familiarity with electronic submission preparation a plus
• Excellent written and oral communication skills
• Ability to handle multiple tasks, self-motivate and be detail oriented

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 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 period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year