Associate Director, MDRIM and RAD

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

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Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

Raynham, Massachusetts, United States of America

Job Description:

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

DePuy Synthes is recruiting for an Associate Director, MDRIM and RAD, located in Raynham, Massachusetts, West Chester, PA, Warsaw, IN, Palm Beach Gardens, FLA or NJ 
 

The Associate Director, MDRIM and RAD, provides strategic leadership for Medical Device Regulatory Information Management (MDRIM) and Regulatory Affairs Data (RAD) activities. This role ensures the integrity, governance, and effective use of regulatory data to support compliance, regulatory submissions, and informed decision‑making across the product lifecycle. The position plays a critical role in strengthening regulatory capabilities, enabling digital transformation, and supporting global regulatory readiness within DePuy Synthes. 

Key Responsibilities 

• Provide strategic leadership for MDRIM and RAD activities, ensuring accurate, complete, and compliant regulatory data management. 
• Oversee governance, standards, and processes for regulatory data and information management. 
• Partner with Regulatory Affairs, Quality, IT, and business teams to support regulatory submissions and lifecycle management. 
• Interpret evolving regulatory data requirements and assess impacts to systems, processes, and reporting. 
• Support regulatory inspections, audits, and internal assessments related to regulatory data and systems. 
• Drive continuous improvement and digital enablement initiatives to enhance regulatory data quality and efficiency. 
• Serve as a senior advisor on regulatory information management and data strategy topics. 
• Lead, mentor, and develop team members, fostering a culture of accountability, compliance, and innovation. 

Qualifications 

Education: 

• Bachelor’s degree in Regulatory Affairs, Information Systems, Life Sciences, Engineering, or a related discipline (required). 
• Advanced degree or professional certification in Regulatory Affairs, Data Management, or related fields (preferred). 
   

Experience and Skills: 

Required: 

• Typically 8–10 years of progressive experience in regulatory affairs, regulatory information management, or regulatory data governance within a regulated industry. 
• Strong understanding of regulatory data requirements and information management principles. 
• Experience supporting regulatory submissions, lifecycle management, and compliance activities. 
• Demonstrated ability to translate regulatory requirements into effective data and system solutions. 
   

Preferred: 

• Experience in medical devices, healthcare, or other highly regulated industries. 
• Familiarity with Regulatory In