Associate Director, Regulatory Affairs

Associate Director, Regulatory Affairs – 2406217663W

Description

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 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 worlds 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 rapport with FDA reviewers, project team members, and other stakeholders.

Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups.

Carry out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Work with others as a team player to successfully achieve strategy. Must be cooperative and work well with all functional groups.

Responsible for providing performance feedback to direct reports as well as coaching and assistance in their development.

Responsible for communicating business related issues or opportunities to next management level

Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Performs other duties assigned as needed

A pre-identified candidate is being considered for this role. However, all applications will still be considered.

Qualifications

A minimum of a Bachelors Degree in Physical or Biological Science or a related field of study.

A very strong understanding of the Medical Device industry.

Extensive training and education in Regulatory Affairs as related to worldwide product approvals.

A minimum of 10 years of experience in all aspects of Regulatory Affairs in the Medical Device Industry.

Extensive hands on experience in activities such as product approval applications, crisis management such as product recalls, FDA inspections.

Strong understanding of Medical Device regulations / standards and Quality principles.

Written and verbal communication skills

Ability to manage multiple priorities effectively.

Strong interpersonal and organizational and problem solving skills.

Ability to make difficult and often unpopular decisions.

Strong negotiation skills as it relates to regulatory bodies worldwide.

Lead by example.

A pre-identified candidate is being considered for this role. However, all applications will still be considered.

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 .

Primary Location NA-US-Minnesota-Plymouth

Organization SterilMed, Inc. (6215)

Job Function Regulatory Affairs

Req ID: 2406217663W