Senior Regulatory Affairs Specialist (Wound Closure & Healing) - MedTech Surgery

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:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America, Remote (US)

Job Description:

About Surgery

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 surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

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

We are searching for the best talent for a Senior Regulatory Affairs Specialist to support our Wound Closure and Healing group. Preference will be given to candidates located within a commutable distance of Raritan, NJ however remote work options will be considered on a case by case basis and if approved by the company.

Purpose: The Senior Regulatory Affairs Specialist (Regulatory Affairs Specialist III) provides regulatory guidance to project teams in strategic planning and related submissions to support Ethicon Wound Closure & Healing (WCH) products. Under minimal supervision, the individual is responsible for developing and executing global regulatory strategies to support new, modified and currently marketed medical devices. This includes the preparation of regulatory documentation for submissions to regulatory health authorities (i.e. European Notified Body, BSI, European MDR, and FDA). He/she guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. The Specialist III helps to define data and information needed for regulatory actions in conjunction with cross-functional teams. He/she guides conformance with applicable regulations through the development of best practices for Regulatory Affairs processes, procedures, and systems.

You will be responsible for:

· Ensures compliance with regulatory agency regulations and interpretations.

· Prepares responses to regulatory agencies' questions and other correspondence.

· Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.

· Provides solutions to a variety of problems of moderate scope and complexity.

· Researches and collects data; and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates.

· Advises on regulatory labeling requirements specifications for modified products, and reviews product labeling to ensure compliance.

· Provides regulatory guidance to project teams and responds to product information requests.

· Provide Regulatory Affairs support during internal and external audits and assists in leading the development best practices for Regulatory Affairs.

· Represents Regulatory Affairs on cross-functional project teams.

Functional and Technical Competencies:

· Leverages scientific and technical understanding of regulated products within the scope of responsibility to provide regulatory input to product development and lifecycle management and evaluate regulatory impact on products.

· Contributes to the development and execution of effective, results-oriented regulatory strategies aligned with business objectives, focusing on the priorities that matter most for patients and the business.

· Evaluates available facts, benefits, risks, and Credo considerations to support sound decisions, seeking guidance as appropriate in ambiguous or unclear situations.

· Supports complex projects and delivers with discipline and accountability by establishing clear priorities, using facts to solve problems, and making timely and effective decisions to execute project…