Senior Program Lead Regulatory Affairs

Johnson & Johnson • Plymouth, MN

10h • Onsite

About The Position

Johnson & Johnson MedTech is currently seeking a Sr Program Lead, Regulatory Affairs to join our team located 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. Learn more at https://www.jnj.com/medtech. The primary role is to develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards.

Requirements

• Bachelor’s degree in engineering, Physical or Biological science or related field of study
• 6+ years’ experience in the medical device industry
• at least five (5) years in Regulatory Affairs of Medical Devices.
• 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.

Nice To Haves

• MS degree preferred.
• Regulatory experience with devices containing software preferred.

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.
• 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.

Benefits

• eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior