Senior Regulatory Affairs Program Lead; OTTAVA)

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 Med Tech, 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.

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Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
Job Posting Locations:
Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America, Remote (US), Santa Clara, California, United States of America

About Surgery. Fueled by innovation at the intersection of biology and technology, we are 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 is 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.

We are searching for the best talent for a Senior Regulatory Affairs Program Lead to support our Instrumentation & Accessories team under the OTTAVA robotics group. Preference will be given to candidates located within a commutable distance of Cincinnati, OH, Santa Clara, CA, or Raritan, NJ however remote options will be considered on a case-by-case basis.

In joining our growing regulatory team, the Sr. Regulatory Affairs Program Lead will help OTTAVA 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.

• 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 information required to obtain global market access, including preparation, writing and filing of FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k) s) and global health authorities’ submissions technical documents.
• Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams.
• Conducts reviews and provides expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission.
• Proactively identifies issues, effectively communicates timelines for project completion, and addresses complex issues that may impact registration status.
• Conducts regulatory evaluation of changes to devices in accordance with requirements of commercial/operating geography and generates the required regulatory submission (including Letters To File) guides conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials.
• Assists in the development of Regulatory Affairs processes.
• Requires up to 25% travel.
• Has previous experience with health authority meetings/interactions.
• Has experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements and their documentation in submissions.

• Minimum of a Bachelor's Degree required, Advanced Degree highly desired; desired areas of study include Science, Engineering, or related field.
• Minimum of 6+ years of related Regulatory Affairs experience within Medical Device is required (4+ years with Advanced Degree).
• Experience with medical device regulatory new product submissions required.
• A demonstrated track record of developing and driving implementation of regulatory strategies.
• Working knowledge of how global regulations…