Director, Regulatory Compliance

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:

Legal & Compliance

Job Sub Function:

Enterprise Compliance

Job Category:

People Leader

All Job Posting Locations:

Santa Clara California United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Director Regulatory Compliance- RAD! This position will be located in Santa Clara CA.

Position Summary:

The Director Regulatory Compliance RAD provides independent strategic regulatory compliance oversight for the RAD business with particular emphasis on robotics-enabled medical technology software and software-enabled devices connected-device and product-cybersecurity compliance and Health Authority/Notified Body inspection readiness and management.

The Director interprets current and emerging regulatory requirements standards and regulator expectations; translates them into risk-based compliance strategies; and provides independent advice challenge escalation and oversight across the product and quality-system lifecycle. The role partners with Quality Regulatory Affairs R&D/Engineering Software Product Cybersecurity Manufacturing/Operations Clinical Legal Supply Chain and business leadership to identify assess communicate escalate and oversee mitigation of material quality and regulatory-compliance risks.

The Director leads inspection-readiness strategy and coordinates significant Health Authority MDSAP and Notified Body inspection-management activities for the assigned RAD scope. The role provides oversight of inspection responses remediation internal-audit follow-up and effectiveness monitoring and may act as delegate to the Senior Director Regulatory Compliance when formally assigned.

Key Responsibilities:

• Develops and implements the RAD regulatory-compliance strategy for assigned products sites legal manufacturers and quality-system processes aligned with MedTech Quality & Compliance and JJRC strategies.

• Provides independent compliance advice challenge and escalation on significant product software cybersecurity quality-system and inspection risks; ensures that risk decisions ownership rationale and required actions are transparent and appropriately governed.

• Monitors the external regulatory environment for requirements and enforcement trends affecting robotics connected devices device software cybersecurity AI-enabled functionality where applicable quality systems and inspections; assesses business impact and drives timely implementation plans.

• Represents RAD Regulatory Compliance in designated risk-management boards quality-review boards management reviews product-development governance compliance councils and leadership forums; escalates material risks to the Senior Director and appropriate governance bodies.

• Provides compliance oversight across the lifecycle of robotics-enabled and computer-assisted medical-device systems including system integration hardware/software interfaces usability and training controls safety/performance evidence postmarket signals and significant product or process changes.

• Challenges and evaluates the adequacy of software compliance controls for embedded software device software functions software accessories cloud or remote functionality interoperability and modular software including lifecycle planning requirements architecture verification validation release maintenance configuration management and change control.

• Assesses whether software functions and changes are appropriately governed under applicable regional requirements including FDA device-software expectations and EU MDR software qualification/classification and ensures material compliance gaps are escalated and remediated.

• Provides independent compliance oversight for AI-enabled functionality when applicable including lifecycle risk controls and predetermined change-control plans or analogous regulatory mechanisms.

• Provides independent regulatory-compliance oversight of the product-cybersecurity quality system for software-enabled and connected RAD products while preserving the legal manufacturers accountability for product safety effectiveness design controls and residual-risk decisions.

• Owns the regulatory-compliance inspection-readiness framework for assigned RAD sites and functions including risk-based readiness assessments mock inspections management and SME preparedness evidence availability and timely remediation of identified gaps.

• Leads or coordinates significant Health Authority MDSAP and Notified Body inspections within assigned scope including inspection strategy escalation cross-site coordination and alignment with Quality Regulatory Affairs Legal Operations and business leadership.

• Provides independent review and oversight of inspection communications and responses including observation interpretation investigation depth risk assessment corrective and preventive actions commitments milestones and evidence of implementation and effectiveness.

• Maintains oversight of inspection commitments through closure and uses inspection audit complaint CAPA postmarket cybersecurity and compliance trend data to identify systemic or recurring risk.

• Oversees a robust risk-based closed-loop internal-audit program for the assigned scope and ensures audit results inform compliance risk assessment and inspection readiness.

• Provides compliance oversight of significant remediation programs special investigations post-acquisition assessments and field-action follow-up including adequate scope governance escalation resources and effectiveness.

• Uses compliance data and regulatory intelligence to identify trends prioritize risk reduction and communicate actionable insights to RAD and JJRC leadership.

• Supports due diligence acquisitions integrations divestitures and new-product introductions with particular attention to robotics software cybersecurity technical documentation and inspection-readiness risks.

• Builds effective relationships across global regional site and functional teams and influences decisions where the role does not have direct authority.

• Develops organizational capability in emerging technology-compliance areas including robotics software connected devices cybersecurity digital health and inspection management.

• Coaches and develops direct reports and matrix team members where applicable and ensures resources are aligned to assigned compliance priorities.

• Manages the assigned compliance budget if applicable and performs other duties as assigned.

Qualifications:

Education:

A minimum of Bachelors or equivalent University degree is required.

Required Skills & Capabilities:

• Minimum 12 years of related experience in a regulated industry including at least 5 years performing leading or managing quality-system/GMP audits or regulatory inspections and supporting manufacturing or product-development organizations .

• Significant experience in medical devices or another regulated healthcare environment operating in an international or global context.

• Demonstrated experience supporting or managing Health Authority and/or Notified Body inspections and internal-audit programs.

• Demonstrated experience with software-enabled or connected medical-device compliance product cybersecurity robotics/digital systems or an equivalent complex electromechanical/software product environment.

• Experience identifying communicating escalating and overseeing mitigation of significant quality or compliance risk.

• Direct people-management experience.

• Current FDA QMSR 21 CFR Part 820 ISO 13485 EU MDR MDSAP and applicable international medical-device quality-system requirements.

• Medical-device risk management including ISO 14971 principles.

• Device software lifecycle and software-change controls

• Product-cybersecurity lifecycle concepts secure development threat and vulnerability management SBOMs patching and postmarket monitoring.

Other:

This position may require up to 20% domestic & international travel

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Regulatory Compliance

Preferred Skills:

The anticipated base pay range for this position is :

$172000.00 - $297850.00

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