SENIOR PROGRAM LEAD 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.

About the role

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

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

Responsibilities

• Ensures 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 the measurement of new products.
• Represent the regulatory function on project teams as a subject matter expert to provide guidance on regulatory requirements and develop worldwide regulatory strategies.
• Coach 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.
• Work collaboratively with cross-functional teams to resolve complex regulatory issues.
• Develop IDE, 510K, and/or PMA submissions and EU Technical Documents for medical devices for commercialization in the USA.
• Generate 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.
• Conduct submission negotiations with regulatory authorities as needed throughout the product lifecycle to ensure timely approvals for new products and product modifications.
• Work with others as a team player to successfully achieve strategy. Must be cooperative and work well with all functional groups.
• Maintain proficiency on regulatory requirements and develop and maintain rapport with FDA reviewers, project team members.
• Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups.
• Perform copy review for internal and external facing documentation to ensure compliance with applicable Federal, State, local, and Company regulations, policies, and procedures.
• Provide regulatory support for internal and external regulatory agency audits.
• Coach junior colleagues in techniques, processes, and responsibilities.
• Responsible for communicating business-related issues or opportunities to the 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.
• Perform other duties assigned as needed.

Requirements

• 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.

Skills

• 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, organizational, and problem-solving skills.

Benefits

• Eligible for an annual performance bonus in accordance with the terms of the applicable plan.
• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Vacation – up to 120 hours per calendar year.
• Sick time – up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year.
• Holiday pay, including Floating Holidays – up to 13 days per calendar year.
• Work, Personal, and Family Time – up to 40 hours per calendar year.

Pay

The anticipated base pay range for this position is $109,000.00 - $174,800.00.