Regulatory Affairs Manager

About the role

We are searching for a Regulatory Affairs Manager to join our DePuy Synthes Orthopaedics team. This position may be based in Raynham, MA; West Chester, PA; Palm Beach Gardens, FL; Synthes, Oberdorf; or Zuchwil. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized orthopedic treatments.

Our Orthopedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. We build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your work will directly support patients on their journey to wellness.

Johnson & Johnson has announced plans to separate our Orthopaedics business into a standalone company, DePuy Synthes. Should you accept this position, it is anticipated that following the transaction, you would be an employee of DePuy Synthes, with employment governed by its processes, programs, policies, and benefit plans.

Responsibilities

• Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new or modified product launches.
• Manages the submission of licenses, authorizations, international registrations, and dossiers for existing products.
• Guides conformance with applicable regulations in product development, claims support, content labeling, and promotional materials.
• Defines data and information needed for regulatory approvals.
• Develops labeling specifications and approves proposed labeling, packaging, advertising, and promotional materials after evaluating conformance to regulations.
• Plans and monitors schedules for regulatory deliverables on projects through completion.
• Leads in the development of best practices for Regulatory Affairs processes.
• Represents Regulatory Affairs on cross-functional project teams.
• Partners with other functions to define and obtain data for regulatory submissions.
• May work directly with International Affiliates.
• Provides Regulatory Affairs support during internal and external audits.
• Communicates business-related issues or opportunities to next-level management.
• Ensures compliance with all Company guidelines related to Health, Safety, and Environmental practices for self and team.
• Ensures personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.
• Performs other duties as assigned.

Requirements

• Bachelor’s degree or equivalent.
• 6 years of related experience.
• Experience in the Medical Device industry or medical field.

Preferred Qualifications

• Experience with power devices is highly preferred.
• Demonstrated knowledge of US and EU Medical Device Regulations.
• RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society or advanced degree in Regulatory Affairs.
• Ability to travel up to 10%, both domestic and international.

Pay

The anticipated base pay range for this position is $117,000.00 - $201,250.00.

Benefits

Subject to the terms of their respective plans and date of hire, employees are eligible for the following benefits:

• Retirement and Savings: Participation in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Time Off:
  • Vacation – 120 hours per calendar year.
  • Sick time – 40 hours per calendar year (48 hours for Colorado residents; 56 hours for Washington residents).
  • 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, or 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.

For additional general information on Company benefits, visit https://www.careers.jnj.com/employee-benefits.