Senior Regulatory Affairs Program Lead (Monarch) - MedTech Surgery
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 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. 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 Robotics and Digital Solutions business. The preference for this role is a Flex/Hybrid schedule and be based in the Santa Clara, CA office. Remote work options may be considered on a case-by-case basis and if approved by the company. Relocation assistance is not provided. Purpose: The Senior Regulatory Affairs Program Lead provides regulatory guidance to project teams in strategic planning and related submissions to support the Monarch Platform under minimal supervision, the individual is responsible for developing and executing regulatory strategies to support new, modified and currently marketed medical devices. This includes the preparation of regulatory documentation for submissions to regulatory health authorities (i.e. European Notified Body, BSI, European MDR, and FDA). The Senior Regulatory Affairs Program Lead helps to define data and information needed for regulatory actions in conjunction with cross-functional teams. He/she guides conformance with applicable regulations through the development of best practices for Regulatory Affairs processes, procedures, and systems.
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 Class II medical device regulatory product submissions required.
- Previous experience with health authority meetings/interactions required
- A demonstrated track record of developing and driving implementation of regulatory strategies.
- Working knowledge of Cybersecurity regulations, requirements for software as a medical device, including devices with AI/ML.
- Working knowledge of requirements for medical devices that include electronic components and associated testing (IEC 60601).
- Excellent communication skills for effective collaboration with cross-functional partners.
- Strong attention to detail.
- 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.
- 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.
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
- Write and file FDA submissions (e.g., Q-submissions, IDEs, 510(k)s).
- 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
- Guides conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials.
- Assists in the development and enhancement of Regulatory Affairs processes.
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 period
- 10 days Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
