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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 organization's 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 Bachelor's 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.