Manager, Regulatory Affairs (International Regulations) - 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:
People Leader

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

Job Description:

We are searching for the best talent for a Manager, Regulatory Affairs (International Regulations) to be located in Irvine, CA.  This role will work a Flex/Hybrid schedule with 3 days per week in office.

Purpose: The Manager, Regulatory Affairs, International Registrations develops and implements regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards.

You will be responsible for:


* Manages a team of individual contributors and/or supervisors, ensuring the effective identification and preparation of detailed international registration documentation that supports all stages of a medical device's lifecycle, from initial product registration through end-of-life, while meeting the documentation needs for international JNJ affiliates.


* Directs resources to develop and implement methods for planning, directing, coordinating, and controlling the submission of international Regulatory documents to Regulatory agencies, including responses to global Health Authority inquiries.


* Develops and sustains strategic relationships with RA affiliates, advising on the development and execution of local registration strategy.


* Benchmarks Regulatory Affairs strategies, assessments, and policies to guide cross-functional teams on international RA issues in developing registration plans to ensure timely commercialization of new and modified products in international markets.


* Ensures compliance by communicating the interpretation of new and changing government regulations to uphold regulatory/government standards.


* Oversees the maintenance of Regulatory Affairs databases and communication tools, including the SharePoint site, Regulatory databases, request tracking systems, and electronic libraries.


* Assists with the development of product policies by reviewing, and revising company SOPs as required.


* Supervises interaction with internal and external stakeholders to manage the procurement of necessary documentation for international regulatory activities.


* Develops tactical plans for global planning to ensure visibility, alignment, and optimal resource allocation.


* Provides support for internal ...