Director, Medical Device Interface, Regulatory Affairs

Johnson & Johnson Innovative Medicine

4d • $164,000 - $282,900 • Hybrid

About The Position

Johnson & Johnson Innovative Medicine R&D is recruiting a Director, Medical Device Interface, Regulatory Affairs to provide strategic regulatory leadership for medical devices used in medicinal product development, including investigational devices supporting global clinical programs. We are seeking a hands-on leader who is comfortable diving into details while also shaping scalable approaches that support long-term portfolio and organizational goals. This role serves as a regulatory and clinical medical device subject matter expert, working across all JJIM therapeutic areas with an initial focus on supporting novel oncology programs. The position requires deep global expertise in medical device regulations, particularly investigational devices, combined with a strong working knowledge of drug development processes. The successful candidate will lead global regulatory strategies for the device component of clinical programs, contribute to the development of infrastructure for investigational device processes and drive the execution of these strategies and related filings while partnering across Regulatory Affairs, Clinical, R&D, Quality, and other functions.

Requirements

• Minimum of a Bachelor's degree in a scientific or related discipline plus a minimum of 10 years of experience in a regulated healthcare industry is required
• Strong regulatory affairs expertise in medical devices, including in-depth knowledge of EU device regulations and broad understanding of global device regulatory framework is required.
• Demonstrated experience supporting device development, supporting device clinical investigations, and other device-related regulatory submissions is required.
• Both hands-on experience with EU clinical investigational device submission systems and direct, practical involvement in preparing or owning key components of CIA applications is required.
• Experience preparing regulatory submission content, supporting Health Authority interactions, and leading cross-functional regulatory planning is required.
• Strong understanding of global regulatory requirements and experience operating effectively within matrixed, multinational organizations is required.
• Experience in strategic planning, technical data summarization, and cross-functional project leadership is required.
• Intellectual curiosity, learning agility, and adaptability to work in emerging areas where regulatory precedent may be limited and across multiple product modalities, including pharmaceuticals, devices, and combination products.

Nice To Haves

• Strong regulatory knowledge in device development and submissions, including IDEs, CIAs, ITAs, and marketing applications for devices (ex. 510(k), De Novo, CE mark), lifecycle management activities is preferred.
• Experience supporting combination products and programs integrating device and pharmaceutical/biologic development is strongly preferred.
• Oncology experience is desirable.

Responsibilities

• Leading medical device aspects of development programs and device activities; guiding and directing the team on the requirements to fulfil investigational and non-investigational device requirements.
• Providing leadership and regulatory direction to drive device infrastructure and business strategy decisions
• Providing support and inputs for quality system processes related to investigational devices, regulatory procedures, investigational device applications
• Driving global regulatory strategies for devices used in clinical development, ensuring alignment with overall drug regulatory strategies.
• Defining and driving filing strategies for investigational device submissions, including IDEs, Clinical Investigation Applications (CIAs), and support device components of IND and CTA submissions.
• Preparing, reviewing, and executing regulatory submissions and supporting evidence packages, directly or through management of CROs, vendors, or external partners.
• Providing regulatory oversight for clinical trial-related device labeling and documentation, including Instructions for Use (IFU), investigator materials, and associated records.
• Ensuring compliance with applicable global device regulations and standards, including EU MDR, national competent authority requirements, FDA expectations, design controls, risk management, human factors/usability considerations, and other regional requirements.
• Identifying, assessing, and proactively managing regulatory risks associated with device development and clinical investigations.
• Preparing for and driving and/or supporting interactions with Health Authorities on device-related matters, including development of briefing materials and responses to agency questions.
• Ensuring clinical protocols and development plans align with applicable device regulatory requirements.
• Providing regulatory support throughout development, clinical investigation, registration, lifecycle management, inspections, audits, litigation support, and product complaint activities.
• Advising teams on required device documentation, submission content, and filing strategies in collaboration with Local Operating Companies (LOCs) and global stakeholders.
• Coordinating regulatory activities to ensure timely submission readiness, tracking critical path activities and key milestones.
• Supporting preparation, submission, acceptance, and maintenance of regulatory filings, including INDs, CTAs, CIAs, MAAs, IDEs for device related information.
• Liaising with LOCs to ensure country-specific submission packages are delivered according to agreed timelines and to track submissions and authority responses.
• Representing teams in interactions with regulatory agencies, including organizing and leading meetings with specific device content where required.
• Supporting Global Regulatory Leads through project management, planning, and execution of major regulatory submissions and Health Authority interactions.
• Participating in global regulatory team meetings and contribute to the development and continuous improvement of device and investigational-device regulatory QMS processes.
• Partnering with regulatory colleagues to monitor the competitive and evolving device regulatory landscape, including agency perspectives, precedents, labeling practices, and disease-area-specific considerations.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director