Director, Regulatory Affairs (Monarch Surgical Robotics) - MedTech Surgery

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:

People Leader

All Job Posting Locations:

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 Director, Regulatory Affairs to support our Monarch robotics platform.  This role will be based in Santa Clara, CA and will work a Flex/Hybrid schedule.  Relocation assistance may be available on a case-by-case basis.

Purpose: The Director, Regulatory Affairs will engage with new product development teams & regional partners to establish regulatory strategies, participate in creation and review of key product development deliverables and author regulatory documents (510ks, technical files). Provide support for currently marketed products, including review of product/ manufacturing process changes, supplier changes, new and revised engineering protocols and reports, and product labeling.

You will be responsible for:

• Develop global regulatory strategies to gain earliest possible, least burdensome regulatory approval in US and other international markets for new or modified products.
• Ensures required content for regulatory submissions are defined and oversee the preparation of submissions.
• Develop and manage submission timelines & resources to support regulatory milestones.
• Represent Regulatory Affairs on the Platform Leadership Team.
• Build and effectively lead high-performing Regulatory team.
• Monitor and provide management with impact of changes in the Regulatory environment.
• Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions in coordination with management.
• Ensures change control documents are reviewed and regulatory impact for external and internal documents are ascertained and rationales to file documentation for modifications to devices are established.
• Identify gaps in product development plans that may pose regulatory issues and come up with novel development strategies.
• Provide review and approval of all external facing communications advertising and promotional labeling to ensure compliance with corporate policy, US and international laws and regulations
• Participate in FDA, notified body and other regulatory body inspections.
• Establish processes and systems to ensure efficient and effective RA operations.

Qualifications / Requirements:

• Minimum of a Bachelor’s Degree in a scientific or technical discipline required; Advanced Degree strongly preferred.
• Minimum of 7-10+ years of experience in Medical Device Regulatory Affairs with specific experience with preparing domestic and international regulatory submissions required. Robotics experience highly desired.
• 3-5+ years of managerial experience (direct reports) required.
• SaMD (Software as a Medical Device) regulatory experience is required.
• Shape and contributes ideas that challenge thinking, proposes and tries new novel approaches
• Experience in Q-sub, pre-submission negotiation process
• Worki