Manager, Regulatory Affairs - Biosense Webster, Inc.

Biosense Webster, part of the Johnson & Johnson MedTech family, is currently recruiting for a Manager, Regulatory Affairs.

This role will work a Flex/Hybrid schedule and must be located within a commutable distance of Irvine, CA .

About Johnson & Johnson

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 https://www.jnj.com/.

DUTIES & RESPONSIBILITIES

• Ensure compliance with global regulations and regulating agencies.

Interpret the intent of regulations and policies and provide such information to project teams and management.

• Instill and drive a regulatory culture.

Establish and support policies and standards for new products.

• Manages the generation of 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.

• Develop IDE/510K/ and PMA submissions for class II and III medical devices for commercialization in the USA.

• Develop Technical File/ Design Dossier submissions for class II and III medical devices for CE Mark Approval.

• Conduct submission negotiations with the FDA as needed, including pre-submission identification of requirements and strategy and post submission negotiations to ensure timely approval.

• Maintain proficiency on regulatory requirements; develop and maintain rapport with FDA reviewers, project team members.

• Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups.

• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.

Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

• Responsible for ensuring that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.

• Works with others as a team player to successfully achieve strategy.

Must be cooperative and work well with all functional groups.

• Directly or through subordinate staff, generates documentation to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by BWI and/or J&J affiliates.

• Responsible for providing performance feedback to direct reports as well as coac...