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 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.
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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 coaching and assistance in their development.
· Assist in the identification and management of departmental project and personnel issues.
Responsible for communicating business related issues or opportunities to next management level · Responsible for ensuring personal and Company compliance with all Federal, State local, and Company regulations, policies, and procedure · Perform Copy Review for internal and external facing documentation to ensure compliance with applicable Federal, State, local and Company regulations, policies, and procedures.
The base pay range for this position is $ to $ based on experience.
The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus.
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 may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.
Additional information can be found through the link below.
https://www.
areers.
nj.
om/employee-benefits Qualifications EXPERIENCE AND EDUCATION · Minimum of a Bachelors Degree required, Advanced Degree strongly preferred; desired fields of study include Engineering, Physical or Biological science or related field.
· Minimum 6-8+ years of relevant experience with at least five 5+ years in Regulatory Affairs of Medical Devices.
· At least 2+ years of direct supervisory experience.
· Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, FDA and EU MDD/MDR /ECC Device Law/Regulations, Worldwide Regulatory Requirements/Procedures, Project Management, and Negotiations.
· Good working relationship with FDA Notified Bodies.
· International clinical and regulatory experience desired.
· Prefer experience in the cardiovascular/cardiology field.
· Ability to manage multiple priorities effectively.
· Strong interpersonal and organizational and problem solving skills.
· Ability to make difficult and often unpopular decisions.
· Strong negotiation skills as it relates to regulatory bodies worldwide.
· Up to 10% travel, both domestic & international, 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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
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