Job Description: JOB TITLE
Sr. Regulatory Affairs Specialist
Develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards.
DUTIES & RESPONSIBILITIES
This position will be focused on EU MDR. The most important skill set would be experience with writing technical documents to obtain or maintain CE mark for marketing in the European Union.
• Ensure compliance with global regulations and regulating agencies. Interpret the intent of regulations and policies and provide such information to project teams and management.
• Develop Technical Documentation Files following the requirements of the EU Medical Device Regulation for class II and III medical devices to obtain or maintain CE Marking.
• Conduct submission negotiations with the European Notified Bodies 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 Notified Body 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.
• Follow all Company guidelines related to Health, Safety and Environmental practices.
• Comply 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, EU Medical Device Regulation, FDA Device Law/Regulations, World Wide Regulatory Requirements/Procedures, Project Management, and Negotiations.
• 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