Associate Director, Regulatory Affairs

Johnson & Johnson is currently seeking an Associate Director, Regulatory Affairs.

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

Duties and Responsibilities:

This is not meant as an all-inclusive list but as top-level list of duties that this person generally completes:

• Ensure compliance with global regulations and regulating agencies.

Interpret the intent of regulations and policies and provide such information to project teams and management.

• Instill and drive a regulatory culture.

Establish and support policies and standards for new products.

• Develop and execute worldwide strategies for product registration, notification, or pre-market approval requirements.

• Partner with WW Clinical Operations to develop clinical strategies and ensure compliance with local, state, and Federal regulations for conducting clinical trials worldwide.

• Manage the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by BWI and/or J&J affiliates.

• Directly or through subordinate staff, develop US IDE/510K/ and PMA submissions for class II and III medical devices, and EU Design Dossiers and Technical Files.

• Directly or through subordinate staff, generate documentation to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by BWI and/or J&J affiliates.

• Conduct submission negotiations with the FDA as needed, including pre-submission identification of requirements and strategy and post submission negotiations to ensure timely approval.

• Maintain proficiency on regulatory requirements; develop and maintain ...