Senior Regulatory Affairs Program Lead - Biosense Webster, Inc.

Johnson & Johnson; Irvine (CA); Hybrid; USD 105,000 - 170,000; Full time

Job summary

A leading company in healthcare innovation is seeking a Senior Regulatory Affairs Program Lead to ensure compliance and develop regulatory strategies for its Electrophysiology business. This role is essential in guiding cross-functional teams through complex regulatory landscapes and ensuring timely product commercialization while adhering to all relevant standards.

Benefits

Annual performance bonus

Medical, dental, and vision insurance

Retirement plan (401k)

Paid vacation and sick time

Qualifications

• Minimum of a Bachelor’s degree required; Advanced Degree strongly preferred.
• At least 6+ years in the medical device industry, 4+ years in Regulatory Affairs.
• Class III PMA experience required.

Responsibilities

• Develop and implement regulatory strategies and processes.
• Ensure compliance with global regulations and provide guidance as a subject matter expert.
• Conduct negotiations with regulatory authorities for timely approvals.

Skills

Regulatory Affairs

Project Management

Negotiation

Communication

Interpersonal Skills

Problem-Solving

Education

Bachelor's degree

Advanced Degree

Job description

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 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 required, Advanced Degree strongly preferred.
• At least 6+ years of relevant experience in the medical device industry with at least four (4) years in Regulatory Affairs of Medical Devices.
• Class III PMA experience is required.
• Experience in the cardiovascular/cardiology field preferred.
• Regulatory experience with devices containing software preferred.
• Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, FDA Device Law/Regulations, Worldwide Regulatory Requirements/Procedures, Project Management, and Negotiations.
• Strong understanding of Medical Device regulations / standards and Quality principles.
• Must be able to communicate effectively in a professional environment.
• Must be able to influence without authority.
• Ability to make difficult and often unpopular decisions.
• Ability to manage multiple priorities effectively.
• Strong interpersonal and organizational and problem-solving skills.
• This role will work a Flex/Hybrid schedule at Irvine, CA.
• Travel: Up to 10% both domestic and international.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

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The anticipated base pay range for this position is :

The anticipated base pay range for this position is $105,000 to $169,050.

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

#LI-BF1