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. Learn more at jnj.com .

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.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

Oberdorf, Basel-Country, Switzerland, Zuchwil, Switzerland

Job Description:

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 Synthes, Oberdorf; Zuchwil or US: Raynham, MA; West Chester, PA; 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.  Are you passionate about improving and expanding the possibilities of Orthopedics? Ready to join a team that’s reimagining how we heal? 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.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes, and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Summary: The RA 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/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. Guide conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. The RA manager serves as the company’s regulatory expert and is responsible for communications with FDA and international regulatory agencies.

 You will:

Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/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

Provide Regulatory Affairs support during internal and external audits

Responsible for communicating business related issues or opportunities to next management level

Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Performs other duties assigned as needed

Qualifications: 

Required:

Bachelor’s degree or equivalent

6 years of related experience

Experience in the Medical Device industry or medical field

Preferred:

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

Other:

Ability to travel up to 10% may be required both domestic and international

#LI-AM2

Required Skills:

Preferred Skills:

Business Writing, Compliance Risk, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Operations Management, Policy Development, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking, Team Management