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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.

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, 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)). 

• Employees are eligible for the following time off benefits: 

  • 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  

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers  or contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking

 

 

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00

Additional Description for Pay Transparency: