Associate Director, MDRIM and RAD

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

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 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 decisionmaking 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:

• Bachelors 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 810 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 Information Management (RIM) systems and digital transformation initiatives.
• Experience supporting regulatory audits or inspections.
• Experience working in a global or matrixed organization.
• Regulatory Affairs Certification (RAC) or equivalent.
• Strong leadership stakeholder management and problemsolving skills.
• Excellent written and verbal communication skills.
  

Other:

Language: English required.

Travel: Limited; occasional domestic or international travel.

Certifications: RAC or relevant data / regulatory certifications preferred but not required.

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Required Skills:

Preferred Skills:

Business Writing Compliance Risk Developing Others Fact-Based Decision Making Inclusive Leadership Industry Analysis Innovation Leadership Legal Support Managing Managers Operations Management Policy Development Product Licensing Public Policies Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Strategic Thinking

The anticipated base pay range for this position is :

137000.00 - 274000.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. 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 period10 days Volunteer Leave 32 hours per calendar year Military Spouse Time-Off 80 hours per calendar year For additional general information on Company benefits please go to: - Experience:

Director