Senior Regulatory Affairs Program Lead - Electrophysiology

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, Remote (US)

Job Description:

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Senior Regulatory Affairs Program Lead.  This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

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 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.

Qualifications/Requirements:

• Minimum of a Bachelor’s degree requ