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

Johnson & Johnson•Santa Clara, CA

1d•$189,000 - $325,450•Hybrid

About The Position

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 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.

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.
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
Working knowledge of IEC 60601-series standards
Prior experience with electro-mechanical software-driven devices
Superior written and verbal communication and presentation skills.
Track record of successfully obtaining market clearance and/or approvals domestic and international
Ability to translate and simplify technical content or regulations and communicate to stakeholders
An approachable individual who provides a high level of teamwork and cross-functional collaboration.
Must be highly organized with the ability to manage multiple projects/tasks simultaneously and effectively prioritize projects and tasks.
Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820.
Up to 20% travel may be required.

Nice To Haves

Robotics experience highly desired.

Responsibilities

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.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits