Johnson & Johnson Careers
Sr. Regulatory Affairs Specialist
Requisition ID: 9189190311
Biosense Webster, Inc (BWI), a member of Johnson & Johnson's Family of Companies, is recruiting for a Sr. Regulatory Affairs Specialist to be located in Irvine, California.
Biosense Webster, Inc., is recognized worldwide as an industry leader in endocardial diagnostics and therapy. Guided by the needs of electrophysiologists and cardiologists, the company has pioneered innovative technological advancements ranging from the first deflectable tip catheter to today's most sophisticated three-dimensional cardiac mapping and navigation systems. Biosense Webster, Inc., combines leading-edge technology with a tradition of quality and responsiveness while partnering with the physician to optimize patient outcomes.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Duties & Responsibilities
As the Sr. Regulatory Affairs Specialist you will build regulatory submissions and assessments (in compliance with applicable regulations and standards) to ensure timely global commercialization of products.
Under moderate supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, responsible for the following Regulatory activities:
• Build and implement regulatory strategies and processes to ensure timely global commercialization of products in compliance with applicable regulations and standards.
• Author regulatory submissions and assessments for class II and III medical devices to be distributed in the US to ensure timely global commercialization of products in compliance with applicable regulations and standards.
• Author technical files and design dossiers for products to be distributed in the EU.
• Prepare international documentation to support product registration internationally.
• Directly communicate with FDA and other Regulatory agencies in preparing responses to submissions and in support of agency audits.
• Evaluate proposed changes to product design or manufacturing processes and assess impact of the proposed changes with regard to worldwide approvals and internal BWI policies and procedures.
• Participate on new product development teams.
• Review and approve new product development and product modification documentation.
• Write, review and revise company SOPs as required.
• Communicate business related issues or opportunities to next management level.
• Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Perform other duties assigned as needed.
• A minimum of a Bachelor’s Degree in combination with a minimum of 4 years experience in a Regulatory Affairs related discipline in the medical device or pharmaceutical industries OR an advanced degree with a minimum of 2 years experience in Regulatory Affairs related discipline in the medical device or pharmaceutical industries is required
• A degree in an Engineering, Physical or Biological science is highly preferred
• Demonstrated track record of developing executable global strategies that align with business deliverables is preferred
• Demonstrated experience in preparing and submitting 510(k)s is required
• Previous experience supporting the preparation of EU Technical Files is preferred.
• Previous experience with software based medical devices experience is preferred.
• Prior experience interacting with FDA is required
• Previous experiencing working with Notified Bodies and worldwide regulatory registrations is preferred.
• Previous experience working with cross functional teams within a matrix environment is required.
• RAC accreditation (through RAPS) is preferred.
• Previous Project Management experience is preferred.
• This position is located in Irvine CA or Irwindale CA, and may have up to 10% domestic or international
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.
Biosense Webster Inc. (6010)