SENIOR PROGRAM LEAD REGULATORY AFFAIRS

About this role

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 jnj.com

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: Regulatory Affairs Group

Job Sub Function: Regulatory Affairs

Job Category: Professional

All Job Posting Locations: Plymouth, Minnesota, United States of America

Job Description: Johnson & Johnson MedTech is currently seeking a Sr Program Lead, Regulatory Affairs to join our team located in Plymouth, MN.

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

JOB SUMMARY Develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards.

DUTIES AND RESPONSIBILITIES Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: • Ensures compliance with global regulations and regulating agencies.  Interpret the intent of regulations and policies and provide such information to project teams and management.

• Instills and drives a regulatory culture.  Establish and support policies and standards for the measurement of new products.

• Represents the regulatory function on project teams as a subject matter expert to provide guidance on regulatory requirements and develop worldwide regulatory strategies.

• Coaches project teams on input for product labeling, claims support, promotional and scientific materials, and other related activities to ensure all regulatory requirements are met throughout the development process.

• Works collaboratively with cross functional teams to resolve complex regulatory issues.

• Develops IDE, 510K, and/or PMA submissions and EU Technical Document for medical devices for commercialization in the USA.

• Generates 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.

• Conducts submission negotiations with regulatory authorities as needed throughout the product lifecycle to ensure timely approvals for new products and product modifications.

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

• Maintains proficiency on regulatory requirements and develop and maintain rapport with FDA reviewers, project team members.

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

• Performs Copy Review for internal and external facing documentation to ensure compliance with applicable Federal, State, local and Company regulations, policies, and procedures.

• Provides regulatory support for internal and external regulatory agency audits.

• Coaches junior colleagues in techniques, processes, and responsibilities.

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

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

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

• Performs other duties assigned as needed.

EXPERIENCE AND EDUCATION • Bachelor’s degree in engineering, Physical or Biological science or related field of study MS degree preferred.

• 6+ years’ experience in the medical device industry with at least five (5) years in Regulatory Affairs of Medical Devices.

• Regulatory experience with devices containing software preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATION/LICENSES AND AFFILIATIONS • Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, FDA Device Law/Regulations, Worldwide Regulatory Requirements/Procedures, Project Management, and Negotiations.

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

• Must be able to communicate effectively in a professional environment.

• Must be able to influence without authority.

• Ability to make difficult and often unpopular decisions.

• Ability to manage multiple priorities effectively.

• Strong interpersonal and organizational and problem-solving skills.

Additional Information • The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

•  Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, shor

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