Director, Regulatory Compliance

6267-Auris Health Inc. Legal Entity; Santa Clara (CA); On-site; USD 172,000 - 298,000; Full time

Job summary

Johnson & Johnson in Santa Clara, CA, seeks a Director, Regulatory Compliance- RAD to provide independent, strategic regulatory compliance oversight for robotics-enabled medical technology, software, and cybersecurity.

You will lead inspection-readiness, coordinate Health Authority, MDSAP, and Notified Body activities, and partner across Quality, Regulatory Affairs, Legal, and R&D to mitigate regulatory risk.

Qualifications

• Education: A minimum of Bachelor’s or equivalent University degree is required.
• 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.
• Significant experience in medical devices or another regulated healthcare environment, operating in an international or global context.
• Demonstrated experience with software-enabled or connected medical-device compliance, product cybersecurity, robotics/digital systems, or an equivalent complex electromechanical/software product environment.

Responsibilities

• Develops and implements the RAD regulatory-compliance strategy for assigned products, sites, legal manufacturers, and quality-system processes.
• Provides independent compliance advice, challenge, and escalation on significant product, software, cybersecurity, quality-system, and inspection risks; ensures that risk decisions are transparent and appropriately governed.
• Represents RAD Regulatory Compliance in risk-management boards, quality-review boards, management reviews, governance forums; escalates material risks to the Senior Director.

Skills

Regulatory compliance

Quality-system audits

Regulatory inspections

Software in medical devices

Cybersecurity in medical devices

Leadership/people management

Education

Bachelor’s or equivalent University degree

Job description

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

Position Summary

Johnson & Johnson is currently recruiting for a Director, Regulatory Compliance- RAD! This position will be located in Santa Clara, CA. 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, elevate, 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 manufacturer’s 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 Bachelor’s 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

Pay Transparency

The anticipated base pay range for this position is : $172,000.00 - $297,850.00

• 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)).
• This position is eligible to participate in the Company’s 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 period
• 10 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: https://www.careers.jnj.com/employee-benefits

Equal Opportunity Employer

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 https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

Additional Company Information

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 https://www.jnj.com/.