Senior Regulatory Affairs Specialist (WCH & Biosurgery) - 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 https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

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 Healing and Biosurgery business.  This role will work a Flex/Hybrid schedule and be based in the Raritan, N.J. office.  There is NO remote option and relocation assistance is not provided.

Purpose:  The Senior Regulatory Affairs Specialist provides regulatory guidance to project teams in strategic planning and related submissions to support Ethicon Wound Closure & Healing (WCH) and Biosurgery products.  Under minimal supervision, the individual is responsible for developing and executing 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). The Senior Regulatory Affairs Specialist 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 an assist in leading the development best practices for Regulatory Affairs. 
• Represents Regulatory Affairs on cross-functional project teams. 
• 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 / Requirements:

• Minimum of a Bachelor’s Degree required; Advanced Degree strongly preferred