Director, Medical Device Interface, Regulatory Affairs

About this role

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 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: Discovery & Pre-Clinical/Clinical Development

Job Sub Function: Regulatory Science

Job Category: Scientific/Technology

All Job Posting Locations: Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, Raritan, New Jersey, United States of America

Job Description: 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. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for Director, Medical Device Interface, Regulatory Affairs.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-092015 Belgium - Requisition Number: R-092902 Switzerland - Requisition Number: R-092905 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Purpose: 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.

You will be responsible for: • 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.

Regulatory Strategy, Agency Interactions & Submission Execution • 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 info

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