Sr Dir Regulator Affairs Neurovascular

at  Johnson Johnson

Johnson&Johnson is looking for:
Senior Director, Regulator Affairs, Neurovascular
Primary Location: Galway, Ireland
Other Locations: Irvine, CA
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 https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.

Key Responsibilities:

• Build and maintain relationships with regulators in the Neurovascular sector, acting as the primary contact for all regulatory activities with agencies.
• Set the strategic regulatory framework for pipeline development and global product launches within a dedicated R&D budget
• Partner with R&D, Global Strategic Marketing, Supply Chain leaders, and other functional platform leaders to develop and implement the strategy for pipeline development and global launches
• Exercise independent judgment and execution to influence operational results of the business unit; leads, coordinates and balances resource allocation across critical projects; and manage regulatory aspects of lifecycle management of platform
• Lead and develop a Regulatory team to cultivate future leaders
• Partner with the Policy team to monitor the global regulatory landscape, assessing the impact of new regulations on research and development efforts.
• Develop and implement training initiatives for platform and franchise employees on current and emerging regulatory requirements.
• Maintain coordinated communication with global, regional, and local regulatory agencies.
• Ensure company policies, procedures and practices are in compliance with appropriate regulatory requirements
• Secure timely regulatory approvals for key product launches, while evaluating team structure and competencies to align with business and regulatory objectives.
• Identify and assess external innovation opportunities connected to the platform area of responsibility– both screening & technical due diligence (or designate team member)
• Other duties as required.

QUALIFICATIONS

Required:

• Minimum of a B.A./B.S. within a technical related field is required. M.S., M.E. or PhD preferred.
• Previous experience with high-risk medical devices is required.
• Demonstrated track record of formulating global regulatory strategies that align with business results is required.
• Senior leadership experience is required, including line management of multiple levels of reporting.
• Minimum of 12 years of Regulatory Affairs experience in Medical Devices, preferably with both 510k and PMA devices in the US and class III devices in the EU
• Proven track record of success in leading all areas of Regulatory Affairs from early-stage technologies (including First Human Use studies), approvals supporting commercial launch, and post market Life Cycle Management
• Expertise in working directly with the FDA and Notified Bodies, leading all forms of communication and developing effective Regulatory Strategies
• Experience with global regulatory approvals, including NMPA and PMDA.

Preferred:

• Experience working with professional and trade associations is a plus.

Other:

• The preferred location for this position is Galway, Ireland, but candidates in Irvine, CA are also encouraged to apply. The role entails up to 20% domestic and international travel.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

• Build and maintain relationships with regulators in the Neurovascular sector, acting as the primary contact for all regulatory activities with agencies.
• Set the strategic regulatory framework for pipeline development and global product launches within a dedicated R&D budget
• Partner with R&D, Global Strategic Marketing, Supply Chain leaders, and other functional platform leaders to develop and implement the strategy for pipeline development and global launches
• Exercise independent judgment and execution to influence operational results of the business unit; leads, coordinates and balances resource allocation across critical projects; and manage regulatory aspects of lifecycle management of platform
• Lead and develop a Regulatory team to cultivate future leaders
• Partner with the Policy team to monitor the global regulatory landscape, assessing the impact of new regulations on research and development efforts.
• Develop and implement training initiatives for platform and franchise employees on current and emerging regulatory requirements.
• Maintain coordinated communication with global, regional, and local regulatory agencies.
• Ensure company policies, procedures and practices are in compliance with appropriate regulatory requirements
• Secure timely regulatory approvals for key product launches, while evaluating team structure and competencies to align with business and regulatory objectives.
• Identify and assess external innovation opportunities connected to the platform area of responsibility– both screening & technical due diligence (or designate team member)
• Other duties as required