SENIOR PROGRAM LEAD REGULATORY AFFAIRS

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

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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 510K submissions 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 authoriti...