Senior Regulatory Affairs Program Lead
Company: Biosense Webster, Inc.
Position: Senior Regulatory Affairs Program Lead
Location: Irvine, CA
Posted: October 11, 2021
Atrial fibrillation (AFIB) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. 20 million people around the world suffer from AFIB each year.
Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company’s CARTO® 3 System revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.
The successful candidate will develop and implement strategies and processes to achieve timely commercialization of innovative medical products in compliance with applicable regulations and standards.
In this role, you will:
- Instill and drive a vibrant regulatory culture, working among functional groups as a teammate and collaborator to develop successful regulatory strategies.
- Establish and support policies and standards for new products while ensuring compliance with global regulations and regulating agencies.
- Interpret the intent of regulations and policies and provide such information to project teams and management.
- Produce and manage the generation of documentation to be submitted to worldwide governmental regulatory agencies to secure approvals for marketing products manufactured and/or distributed by BWI and/or J&J affiliates.
- Develop IDE, 510(k) and PMA submissions for class II and III medical devices for commercialization in the USA.
- Develop Technical Documentation for class II and III medical devices to support CE Mark approval.
- Support development teams working towards modifying existing devices or creating new products; ensure compliance with design controls, risk management, and domestic and international regulations.
- Ensure timely approvals, communicate and conduct negotiations with the FDA and other regulatory bodies as needed to identify pre-submission requirements and strategy and to resolve post-submission queries and issues.
- Maintain proficiency on regulatory requirements; develop and maintain rapport with FDA/Notified Body reviewers.
- Provide continuing regulatory education and disseminate regulatory information to the product development, marketing, and clinical groups.
- Ensure 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.
- Be responsible for ensuring personal and Company compliance with all Federal, State local, and Company regulations, policies, and procedure.
- A Bachelor’s degree with at least 6 years of related regulatory affairs experience in a health regulated industry experience is required.
- At least 5 years in medical device Regulatory Affairs required.
- Regulatory submission experience (i.e., 510(k), PMA, etc.) is required.
- Regulatory experience with devices containing software preferred
- RA lead on a cross-functional teams (negotiation, leading RA strategy globally) is required.
- Strong interpersonal, organizational and problem-solving skills are required.
- Experience and proven expertise in electrical medical devices and embedded software is strongly preferred.
- Experience in the cardiovascular/cardiology field is preferred.
- Ability to manage and prioritize effectively in a multifaceted environment is required.
- Working knowledge of FDA and EU Medical Device Directive and Medical Device Regulations is required.
- Knowledge of other international medical device requirements (e.g., China, Japan, Australia, Brazil, Russia) is preferred.
- Project Management experience is preferred.
- Experience in evaluating and managing regulatory implications associated with changes in medical device design and manufacturing is required.
- Demonstrated expertise in a broad range of Regulatory Affairs subjects.
- Strong negotiation skills as they relate to regulatory bodies. History of building relationships and successful interaction with FDA and/or Notified Bodies is required.
- International clinical and regulatory experience is desired.
- Ability to make difficult and often unpopular decisions is required.
- This position will be based in Irvine, CA. Domestic and international travel up to 10% may be required.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.