Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech Surgery, Inc.

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, Raritan, New Jersey, United States of America, Santa Clara, California, 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 Program Lead to support our Robotics & Digital Surgery team.  The preferred location for this role is Cincinnati, OH however Santa Clara, CA & Raritan, NJ are also available as a locations.  This role will work a Flex/Hybrid schedule with 3 days per week in-office.  There is NO remote option.  Relocation assistance may be available on a case-by-case basis.

Purpose: In joining our growing regulatory team, the Sr.

Regulatory Affairs Program Lead will help Robotics & Digital Solutions reach US and international regulatory (NPD) approval goals.

Under minimal supervision, the selected candidate will lead regulatory strategy development and execution for the robotic instruments and accessories portfolio.  They will work closely with exceptional engineering and clinical teams,  supporting product development stages, generating submission ready documentation, and authoring regulatory submissions.

Additionally, this individual will support health authority communications.

You Will Be Responsible For:


* Instills and drives a vibrant regulatory culture, working among cross functional groups as a teammate and collaborator.


* Applies strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals.


* Prepares and submits regulatory infor...