Senior Regulatory Affairs Program Lead – Data Strategy, MedTech Surgery
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Raritan • New Jersey • Ohio • United States
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Salary
💰 $109,000 - $174,800 per year
Job Level
About the role
- 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 .
- Experience implementing AI into processes & workflows is highly desired .
- 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.
- RAC Certification strongly preferred .
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)).
- 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 period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory requirementscompliancesystem implementationdata managementdata analysisAI implementationgap analysisdata standardsvalidated processesUnique Device Identification (UDI)
Soft Skills
communication skillsleadershiporganizational capabilitiesinfluencingalignment with stakeholderstranslating needs into requirementsstrategic thinkingproblem-solvingcollaborationadaptability
Certifications
Bachelor's DegreeAdvanced DegreeRAC Certification