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

About this role

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 jnj.com

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.

Job Function: Regulatory Affairs Group

Job Sub Function: Regulatory Affairs

Job Category: Professional

All Job Posting Locations: Cincinnati, Ohio, 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 Instrumentation & Accessories team.  The preferred location for this role is Cincinnati, OH; however Santa Clara, CA is also available as a location . This role will work a Flex/Hybrid schedule with 3 days per week in-office. 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 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 guidance documents in product development, support of claims, content labeling, and promotional materials. • Assists in the development of Regulatory Affairs processes.

Qualifications / Requirements : • 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 impact product registration. • Good communication skills for effective collaboration with cross-functional partners. • Corresponding and collaborating with 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. • Advanced analytical and problem-solving skills. • 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 • Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements and their documentation in submissions.

Johnson & Johnson is an Equal Opportunity Employer.

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