Director, Medical Device Interface, Regulatory Affairs

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

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:

Beerse Antwerp Belgium

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 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 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.

Qualifications & Requirements:

• Education: Minimum of a Bachelors degree in a scientific or related discipline plus a minimum of 10 years of experience in a regulated healthcare industry is required

Skills/Experience:

• 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.
• 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.
• 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.
• Oncology experience is desirable.
• 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.

Required Skills:

Preferred Skills:

Consulting Corporate Governance Design Mindset Drug Discovery Development Fact-Based Decision Making Healthcare Trends Interpersonal Influence Mentorship Public Policies Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Scientific Research Stakeholder Management Strategic Thinking Technical Writing

The anticipated pay range for this position in the primary posting location is:

119200.00 - 204355.00

The anticipated pay ranges for additional locations are:

Belgium- The anticipated base pay range for this position is $119 200 EUR$204355 EUR

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Additional information:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions.



Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans.



For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.