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

Robotics & Digital Solutions, part of the Johnson & Johnson Medtech Surgery, is recruiting for a Senior Regulatory Affairs Program Lead .

The preferred location for this role is Cincinnati, OH however candidates located in Santa Clara, CA or Raritan, NJ will also be considered.

This role will work a Flex/Hybrid schedule with 3 days per week on-site.

There is NO remote option.

Relocation assistance to Cincinnati, OH is available to qualified candidates .

About Johnson & Johnson

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.

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 be working on the robotics, instruments and accessories portfolio RA needs, working closely with exceptional engineering and clinical teams, as well as supporting product development stages and generating submission ready documentation and authoring regulatory submissions.

Additionally, this individual will support health authority communications and participate in strategy development.

Key Responsibilities :

• 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.

This includes conducting reviews and providing 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 identify issues, effectively communicate timelines for project completion, and address complex issues that may impact registration status.

• Conduct regulatory evaluation of changes to devices in accordance with requirements of commercial/operating geography and generate the required regulatory submission (including Letters To File)

• Guides conformance with applicable regulations and guida...