Regulatory Affairs Manager

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

We are searching for the best talent to join our DePuy Synthes Orthopaedics team as a Regulatory Affairs Manager. This position may be based in Raynham, MA; West Chester, PA; or Palm Beach Gardens, FL. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized 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. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

About the role

The Regulatory Affairs Manager leads a team to provide 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. Under minimal supervision, the individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. The RA Manager guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials, and serves as the company’s regulatory expert responsible for communications with FDA and international regulatory agencies.

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 and authorizations for the maintenance of existing products, international registrations, and dossiers
• Guides conformance with applicable regulations in product development, support of claims, 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 schedules for regulatory deliverables on a project and monitors project 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 to assist with regulatory submissions
• May work with International Affiliates directly
• Provides Regulatory Affairs support during internal and external audits
• Responsible for communicating business-related issues or opportunities to the next management level
• Ensures compliance with all Company guidelines related to Health, Safety, and Environmental practices
• For those who supervise or manage a staff, ensures subordinates follow all Company guidelines related to Health, Safety, and Environmental practices
• 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

Qualifications

• Experience with power devices is highly preferred
• Demonstrated knowledge of US and EU Medical Device Regulations preferred
• RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society or advanced degree in Regulatory Affairs, desirable
• Ability to travel up to 10% may be required, 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, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

• Vacation: 120 hours per calendar year
• Sick time: 40 hours per calendar year (48 hours for employees who reside in Colorado; 56 hours for employees who reside in Washington)
• 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