Senior Regulatory Affairs Program Lead - Biosense Webster, Inc.

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 https://www.jnj.com

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Irvine, California, United States of America

Job Description:

We are searching for the best talent for Senior Regulatory Affairs Program Lead to support our Electrophysiology business.  This role will be based in Irvine, CA and work a Flex/Hybrid schedule with 3 days per week in office.

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

You will be responsible for:


* 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 drive 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 documen...