Johnson & Johnson Careers
Senior Regulatory Affairs Specialist
Requisition ID: 8972190308
Biosense Webster, part of the Johnson & Johnson family of companies, is recruiting for Senior Regulatory Affairs Specialist based in Irvine, CA.
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 in 2009 revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.
The primary role of the Senior Regulatory Affairs Specialist is to develop regulatory submissions and assessments (in compliance with applicable regulations and standards) to ensure timely global commercialization of products.
- Develop 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 of Science degree preferably in Engineering, Physical or Biological science is required. An advanced degree is preferred.
- A minimum of 4 years experience in Regulatory Affairs or other related discipline in the medical device or pharmaceutical industries OR an advanced degree with 2 years experience is required.
- Demonstrated track record of developing executable global strategies that align with business deliverables is preferred
- Demonstrated experience for preparing and submitting 510(k)s and preparation of EU Technical Files is preferred.
- Software as a medical device experience is preferred.
- Prior interaction with FDA, Notified Bodies and worldwide regulatory registrations is required.
- Previous experience working with cross functional teams within a matrix environment is required.
- RAC accreditation (through RAPS) is preferred.
- Project Management experience is preferred.
- This position will be located in Irvine, CA and may require up to 10% domestic and/or international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Biosense Webster Inc. (6010)