Director, Reg & Scientific Affairs
Johnson & Johnson Innovative Medicine•Warsaw, IN
•Hybrid
About The Position
This Director role provides strategic leadership at the intersection of regulatory affairs, scientific engagement, and R&D technology enablement. The position plays a critical role in shaping how digital and technology solutions support regulatory compliance, scientific evidence generation, and lifecycle management for DePuy Synthes’ orthopedic portfolio. The Director partners closely with R&D, Quality, Scientific Affairs (Clinical, Pre-clinical and Medical Affairs), and IT leaders to ensure technology‑enabled regulatory strategies that accelerate innovation while maintaining the highest standards of compliance and patient safety and reports into the DePuy Synthes Technology organization.
Requirements
- Bachelor’s degree required in Engineering, Information Technology, or a related field.
- 10-12 years of experience in regulatory affairs, scientific affairs, R&D, or related technology‑enabled functions within medical devices, pharmaceuticals, or life sciences.
- Proven leadership experience at a senior manager or director level, managing complex, cross‑functional teams and programs.
- Strong understanding of regulatory frameworks impacting MedTech (e.g., FDA, EU MDR, ISO standards) and their technology implications.
- Demonstrated ability to translate regulatory and scientific requirements into scalable technology solutions.
- Experience partnering with Regulatory/Scientific Affairs, R&D, Supply Chain and IT organizations to deliver compliant, value‑driven outcomes.
- Strong executive communication, stakeholder management, and decision‑making skills.
- English proficiency required
Nice To Haves
- Advanced degree (Master’s, MBA, or equivalent) preferred.
- Experience supporting medical device or life science products.
- Familiarity with regulatory information management systems (RIMS), document management systems, and data analytics platforms.
- Experience leading digital transformation or modernization initiatives within Regulatory, Scientific Affairs, or R&D environments.
- Global regulatory exposure, including FDA, EU MDR/IVDR, and other international authorities.
- Additional languages preferred.
- PMP, Agile, or relevant IT certifications preferred but not required.
Responsibilities
- Own the R&D Technology strategy and roadmap supporting Regulatory Affairs and Scientific Affairs, aligned to business priorities and global regulatory requirements.
- Serve as the primary technology liaison to Regulatory and Scientific Affairs leadership, translating business and compliance needs into scalable digital solutions.
- Oversee technology platforms supporting regulatory submissions, registrations, product dossiers, labeling, clinical and scientific content, and post‑market evidence.
- Partner with Quality, Clinical, Scientific Affairs, Legal, Privacy, and IT Risk to ensure systems and data meet regulatory, validation, and audit requirements.
- Enable data integrity, traceability, and compliance across the end‑to‑end product lifecycle, including design controls, submissions, and post‑market activities.
- Lead modernization and simplification of Regulatory & Scientific Affairs technology landscapes, reducing complexity and technical debt while improving usability.
- Support global inspections, audits, and regulatory interactions by ensuring system readiness, documentation, and reliable access to authoritative data.
- Provide executive‑level reporting on technology risks, roadmap progress, and investment outcomes related to Regulatory & Scientific Affairs.
- Lead, mentor, and develop a high‑performing team of technology leaders, product owners, and domain experts.
- Drive continuous improvement through adoption of best practices, emerging technologies, and data‑driven insights.
- Lead the application of AI, advanced analytics, and automation to modernize R&D platforms, accelerating product development, improving scientific and engineering insights, and strengthening end‑to‑end decision‑making while enabling scalable, compliant, and efficient R&D operations from discovery through lifecycle management.
Benefits
- 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.
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
