Senior Regulatory Affairs Specialist; OTTAVA)

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, 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.

Learn more at

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Regulatory Affairs Group

Regulatory Affairs

Professional

Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America, Remote (US), Santa Clara, California, United States of America

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

We are searching for the best talent for a Senior Regulatory Affairs Specialist 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 Specialist 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.

• Applies strategic regulatory thinking along with technical expertise to 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 including 510(k) s and global health authorities’ submissions technical documents.
• Proactively identifies issues, effectively communicates timelines for project completion, and addresses issues that may impact registration status.
• 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.

• Minimum of a Bachelor's Degree required, Advanced Degree highly desired; desired areas of study include Science, Engineering, or related field.
• Minimum of 4+ years of related Regulatory Affairs experience within Medical Device is required (3+ 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 impact product registration.
• Good communication skills for effective collaboration with cross-functional partners.
• Corresponding and collaborating with J&J colleagues globally for strategic contribution and achievement of regulatory milestones.
• Evaluating new regulatory requirements as well as regulatory changes and correctly assessing business impact.
• Excellent verbal and written communication skills; strong attention to detail.
• High organization skills with the ability to lead multiple projects/tasks simultaneously and effectively prioritize projects and tasks.
• Strong learning skills for complex technology and presentation skills to allow presentation of complex regulatory strategies in a clear, concise, and comprehensive fashion.
• This position will require up to 25% travel.
• Previous experience with health authority meetings/interactions preferred.
• Experience with medical device software guidance, IEC 60601, sterilization,…