Senior Regulatory Affairs Specialist - 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:
Cincinnati, Ohio, 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 Torax Medical business.

This role will work a Flex/Hybrid schedule and be based in the Cincinnati, OH office.  There is NO remote option and relocation assistance is not provided.

Purpose: The Senior Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Torax Medical.

The individual combines knowledge of scientific, regulatory and business issues to ensure that products, which are developed, manufactured or distributed by J&J MedTech Surgery meet the required legislation the United States and rest of world.

Through your engagement in this role, you will help shape the life-saving field of heart recovery.

You will be responsible for:


* Prepare and submit regulatory documents, including applications for product registrations, amendments, annual renewals to respective health authorities and Notified Bodies (e.g.

US FDA, TUV).


* Collaborate with regional regulatory partners as needed in preparing submissions for global expansion.


* Evaluate proposed changes for regulatory impact and perform any required regulatory submissions/amendments.


* Maintenance of licenses throughout product lifecycle.


* Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes in responsible jurisdictions .


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