Director, Medical Device Interface, Regulatory Affairs

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we innovate across the full spectrum of healthcare solutions to deliver breakthroughs that profoundly impact health for humanity.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

About the Role

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.

Responsibilities

• Lead medical device aspects of development programs and device activities; guide and direct the team on the requirements to fulfill investigational and non-investigational device requirements.
• Provide leadership and regulatory direction to drive device infrastructure and business strategy decisions.
• Support and provide inputs for quality system processes related to investigational devices, regulatory procedures, and investigational device applications.
• Drive global regulatory strategies for devices used in clinical development, ensuring alignment with overall drug regulatory strategies.
• Define and drive filing strategies for investigational device submissions, including IDEs, Clinical Investigation Applications (CIAs), and support device components of IND and CTA submissions.
• Prepare, review, and execute regulatory submissions and supporting evidence packages, directly or through management of CROs, vendors, or external partners.
• Provide regulatory oversight for clinical trial-related device labeling and documentation, including Instructions for Use (IFU), investigator materials, and associated records.
• Ensure 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.
• Identify, assess, and proactively manage regulatory risks associated with device development and clinical investigations.
• Prepare for and drive and/or support interactions with Health Authorities on device-related matters, including development of briefing materials and responses to agency questions.
• Ensure clinical protocols and development plans align with applicable device regulatory requirements.
• Provide regulatory support throughout development, clinical investigation, registration, lifecycle management, inspections, audits, litigation support, and product complaint activities.
• Advise teams on required device documentation, submission content, and filing strategies in collaboration with Local Operating Companies (LOCs) and global stakeholders.
• Coordinate regulatory activities to ensure timely submission readiness, tracking critical path activities and key milestones.
• Support preparation, submission, acceptance, and maintenance of regulatory filings, including INDs, CTAs, CIAs, MAAs, IDEs for device-related information.
• Liaise with LOCs to ensure country-specific submission packages are delivered according to agreed timelines and to track submissions and authority responses.
• Represent teams in interactions with regulatory agencies, including organizing and leading meetings with specific device content where required.
• Support Global Regulatory Leads through project management, planning, and execution of major regulatory submissions and Health Authority interactions.
• Participate in global regulatory team meetings and contribute to the development and continuous improvement of device and investigational-device regulatory QMS processes.
• Partner with regulatory colleagues to monitor the competitive and evolving device regulatory landscape, including agency perspectives, precedents, labeling practices, and disease-area-specific considerations.

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.
• Strong regulatory affairs expertise in medical devices, including in-depth knowledge of EU device regulations and broad understanding of global device regulatory framework.
• Demonstrated experience supporting device development, supporting device clinical investigations, and other device-related regulatory submissions.
• Hands-on experience with EU clinical investigational device submission systems and direct, practical involvement in preparing or owning key components of CIA applications.
• Strong regulatory knowledge in device development and submissions, including IDEs, CIAs, ITAs, and marketing applications for devices (e.g., 510(k), De Novo, CE mark), lifecycle management activities.
• Experience supporting combination products and programs integrating device and pharmaceutical/biologic development is strongly preferred.
• Experience preparing regulatory submission content, supporting Health Authority interactions, and leading cross-functional regulatory planning.
• Strong understanding of global regulatory requirements and experience operating effectively within matrixed, multinational organizations.
• Oncology experience is desirable.
• Experience in strategic planning, technical data summarization, and cross-functional project leadership.
• 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.

Pay

The anticipated base pay range for this position is $164,000.00 - $282,900.00.

Benefits

• 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.
• 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.