Senior Regulatory Affairs Program Lead (Data Strategy) - 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 Senior Regulatory Affairs Program Lead to support Data Strategy for our Surgery group. This role must be based within a commutable distance of Raritan, NJ or Cincinnati, OH and will work a Flex/Hybrid schedule with 3 days per week onsite . Purpose : The Senior Regulatory Affairs Program Lead for regulatory data strategy supports the development, implementation, and continuous improvement of Regulatory systems, data, and Artificial Intelligence (AI) capabilities in alignment with Johnson & Johnson’s MedTech Data & Digital Roadmap. This role partners closely with cross‑functional stakeholders to ensure that regulatory processes, data models, and digital solutions are designed and completed to meet evolving global regulatory requirements while enabling efficiency, data integrity, and strategic insight across the organization.

Responsibilities

• Translate complex regulatory requirements into clear, practical implementation strategies, ensuring that regulations are reflected accurately and efficiently within business processes, and supporting digital systems.
• Lead regulatory strategy and implementation for AI-driven digital and data initiatives, ensuring development of validated, compliant processes and tools to collect, manage, and analyze data that strengthen our competitive position and meet evolving external data- and systems-related regulatory requirements.
• Establish and optimize procedures governing the creation, maintenance, and utilization of regulatory data to ensure integrity, traceability, and compliance.
• Build organizational capabilities in regulatory data standards, processes, and systems.
• Serve as the primary contact for enterprise-wide initiatives, influence, and drive alignment with interested parties.
• Translate Regulatory Affairs’ needs into actionable business requirements to guide the design, development, and deployment of IT solutions, digital tools, and data platforms.
• Support policy efforts by providing input on emerging regulations, industry guidance, and trade association activities.
• Lead organizational readiness for data submissions to external databases (e.g., EUDAMED) including defining data requirements, conducting gap analysis, and ensuring process and system preparedness.

Requirements

• Minimum of a Bachelor’s Degree required , Advanced Degree strongly preferred .
• At least 6+ years regulatory affairs experience within a highly regulated industry required , Medical Device strongly preferred .
• Compliance & governance for Unique Device Identification (UDI) is required .
• System implementation experience is required .
• Knowledge of regulatory requirements in the EU and US, with proven track record of translating regulatory requirements into clear data, system, and business processes.
• Excellent written and verbal communication skills.

Nice-to-haves

• Experience implementing AI into processes & workflows is highly desired .
• RAC Certification strongly preferred .

Benefits

• employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• 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

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