Director, Medical Device Interface, Regulatory Affairs

Johnson & Johnson

Regulatory Affairs Director leading global medical-device strategies and submissions for Johnson & Johnson’s innovative medicines. Guiding clinical programs, agency interactions, and investigational-device infrastructure.

Posted 8/7/2026full-timeRaritan • New Jersey • 🇺🇸 United StatesLead💰 $164,000 - $282,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in medical device regulatory affairs, including strategic leadership in global regulatory strategies, compliance with EU MDR and FDA regulations, and preparation of regulatory submissions for investigational devices. Proven ability to manage cross-functional teams and navigate complex regulatory environments in the healthcare industry.

Highest-signal resume keywords

Medical Device Regulatory Affairs ExpertiseEU MDR ComplianceRegulatory Submission PreparationOncology Program ExperienceCross-Functional Project Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentInvestigational Device ApplicationsIDE and CIA Submission KnowledgeLifecycle ManagementRisk ManagementTechnical Data SummarizationDevice Marketing Applications510(k) and De Novo SubmissionsClinical Investigations SupportCombination Products Experience

Soft Skills

LeadershipStrategic PlanningCollaborationCommunicationProblem-Solving

Industry Keywords

Regulated Healthcare IndustryGlobal Regulatory FrameworksHealth Authority InteractionsQuality Management SystemsMatrixed OrganizationsDevice Regulations and StandardsHuman Factors/Usability Considerations

About the role

Key responsibilities & impact

Provide strategic regulatory leadership for medical devices used in medicinal product development, including investigational devices supporting global clinical programs
Serve as a regulatory and clinical medical device subject matter expert across Innovative Medicine therapeutic areas, initially focusing on novel oncology programs
Lead global regulatory strategies for the device component of clinical programs
Develop infrastructure for investigational device processes and drive execution of regulatory strategies and related filings
Lead medical device aspects of development programs and device activities
Provide leadership and regulatory direction for device infrastructure and business strategy decisions
Support quality-system processes, regulatory procedures, and investigational device applications
Define and drive filing strategies for IDEs, CIAs, and device components of IND and CTA submissions
Prepare, review, and execute regulatory submissions and evidence packages directly or through CROs, vendors, and external partners
Oversee clinical-trial device labeling and documentation, including IFUs, investigator materials, and associated records
Ensure compliance with global device regulations and standards, including EU MDR, competent-authority requirements, FDA expectations, design controls, risk management, and human factors/usability requirements
Identify, assess, and manage regulatory risks associated with device development and clinical investigations
Prepare and support Health Authority interactions, briefing materials, and responses to agency questions
Ensure clinical protocols and development plans align with device regulatory requirements
Provide regulatory support through development, clinical investigation, registration, lifecycle management, inspections, audits, litigation support, and product complaints
Advise teams on device documentation, submission content, and filing strategies with local operating companies and global stakeholders
Coordinate regulatory activities, submission readiness, critical-path activities, and milestones
Support preparation, submission, acceptance, and maintenance of INDs, CTAs, CIAs, MAAs, and IDEs for device-related information
Liaise with local operating companies on country-specific submission packages and authority responses
Represent teams in regulatory-agency interactions and lead meetings involving device content
Support Global Regulatory Leads with project management, planning, and execution of major submissions and Health Authority interactions
Participate in global regulatory team meetings and improve device and investigational-device regulatory QMS processes
Monitor the competitive and evolving device regulatory landscape, agency perspectives, precedents, labeling practices, and disease-area considerations

Requirements

What you’ll need

Minimum of a Bachelor's degree in a scientific or related discipline
Minimum of 10 years of experience in a regulated healthcare industry
Strong medical-device regulatory-affairs expertise
In-depth knowledge of EU device regulations and broad understanding of global device regulatory frameworks
Experience supporting device development and clinical investigations
Experience with device-related regulatory submissions
Hands-on experience with EU clinical investigational-device submission systems
Direct practical involvement preparing or owning key components of CIA applications
Strong regulatory knowledge of IDEs, CIAs, ITAs, device marketing applications, 510(k), De Novo, CE mark, and lifecycle management preferred
Experience supporting combination products and integrated device-pharmaceutical/biologic development strongly preferred
Experience preparing regulatory submission content, supporting Health Authority interactions, and leading cross-functional regulatory planning
Understanding of global regulatory requirements
Experience working effectively in matrixed, multinational organizations
Oncology experience desirable
Experience in strategic planning, technical data summarization, and cross-functional project leadership
Ability to work across pharmaceuticals, devices, and combination products
Knowledge of applicable device regulations and standards, including EU MDR, national competent-authority requirements, FDA expectations, design controls, risk management, and human factors/usability considerations

Benefits

Comp & perks

Retirement plan (pension)
Savings plan (401(k))
Eligibility for the long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year
Sick time for Colorado residents – 48 hours per calendar year
Sick time for Washington residents – 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
Inclusive interview process and accommodations for applicants with disabilities