Sr. Program Lead, Regulatory Affairs

6010-Biosense Webster Inc. Legal Entity

Irvine (CA)

On-site

USD 109,000 - 175,000

Full time

14 days+

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Benefits offered by this job

Annual performance bonus

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) plan

Paid time off

Job summary

Johnson & Johnson in Irvine, CA seeks a Senior Regulatory Affairs professional to develop and implement global regulatory strategies for medical devices. You will ensure compliance with worldwide agencies, craft submissions (IDE/510K/PMA) and guide project teams through regulatory requirements.

Applicants should have a strong background in FDA QSR/ISO 13485, EU MDR, and international experience, with cardiovascular/cardiology exposure preferred.

Qualifications

Experience in Regulatory Affairs, Submission Preparation, FDA Device Law/Regulations.
Strong knowledge of FDA Quality System Regulation and ISO 13485.
Strong knowledge of EU MDR.
International clinical and regulatory experience desired.
Prefer experience in cardiovascular/cardiology field.
Must communicate effectively in a professional environment.

Responsibilities

Ensure compliance with global regulations and regulating agencies.
Interpret regulations and provide guidance to project teams and management.
Develop IDE/510K/ PMA submissions for class II and III medical devices.
Conduct submission negotiations with global regulatory agencies as needed.
Maintain proficiency on regulatory requirements and liaise with reviewers.
Provide regulatory education and disseminate information to product teams.
Prepare documentation for worldwide approvals of products.
Collaborate with cross-functional teams to achieve strategy.
Ensure adherence to Health, Safety and Environmental guidelines.

Skills

Analytical Reasoning

Business Writing

Coaching

Collaboration

Communication

Legal Support

Problem Solving

Product Licensing

Public Policies

Regulatory Affairs Management

Regulatory Compliance

Regulatory Development

Regulatory Environment

Regulatory Reporting

Risk Assessments

Strategic Thinking

Education

Bachelor’s degree

MS degree preferred

Job description

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

Professional

All Job Posting Locations

Irvine, California, United States of America

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Job Summary

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

Duties and 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 the measurement of new products.
Develop IDE/510K/ and PMA submissions for class II and III medical devices.
Conduct submission negotiations with the global regulatory agencies as needed, including pre-submission identification of requirements and strategy and post submission negotiations to ensure timely approval.
Maintain proficiency on regulatory requirements and develop and maintain rapport with regulatory reviewers, project team members.
Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups.
Manage 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.
Work with others as a team player to successfully achieve strategy.
Must be cooperative and work well with all functional groups.
Responsible for communicating business related issues or opportunities to next management level.
Responsible for ensuring 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.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed.

Experience and Education

Bachelor’s degree in engineering, Physical or Biological science or related field of study MS degree preferred. 6+ years’ experience in the medical device industry with at least five (5) years in Regulatory Affairs of Medical Devices. Regulatory experience with devices containing software preferred.

Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations

Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, FDA Device Law/Regulations, Worldwide Regulatory Requirements/Procedures, Project Management, and Negotiations.
Strong knowledge of FDA Quality System Regulation and ISO 13485 Standard is required
Strong knowledge of EU MDR is required
New product development experience is required
International clinical and regulatory experience desired.
Prefer experience in the cardiovascular/cardiology field.
Must be able to communicate effectively in a professional environment.
Must be able to influence without authority.

Additional Information

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 Work, Personal and Family Time - up to 40 hours per calendar year.

Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

Equal Opportunity Employer Statement

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 & 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Required Skills