Develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards.
Essential Experience needed in:
Writing and submitting to the FDA 510Ks
Creating and Updating PMA 30 day notices for USA and Dossiers for European Regulatory Agencies
DUTIES & RESPONSIBILITIES
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:
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 FDA 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 FDA 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.
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 and CERTIFICATIONS/LICENSES:
Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, FDA Device Law/Regulations, World Wide Regulatory Requirements/Procedures, Project Management, and Negotiations.
Good working relationship with FDA.
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
LOCATION & TRAVEL REQUIREMENTS
Location: Irvine, CA, may work remotely per arrangements with manager.
Travel: 10% travel, both domestic and international