Senior Specialist, Regulatory Affairs

At Edwards Lifesciences, we are committed to transforming patient lives through innovative medical technologies. We are seeking a highly skilled and experienced Senior Specialist, Regulatory Affairs to join our team. In this role, you will play a crucial role in ensuring our products meet regulatory requirements and standards, allowing us to continue providing life-saving treatments to patients worldwide. If you are a detail-oriented and knowledgeable regulatory affairs professional with a passion for making a difference in the healthcare industry, we encourage you to apply.

1. Responsible for ensuring compliance with all relevant laws, regulations, and standards related to medical devices and healthcare products.
2. Develop and maintain a deep understanding of global regulatory requirements and communicate updates and changes to relevant stakeholders within the organization.
3. Collaborate with cross-functional teams including R&D, Quality, and Clinical to ensure regulatory requirements are incorporated into product development and manufacturing processes.
4. Prepare and submit regulatory submissions to health authorities, including 510(k), PMA, and CE mark applications.
5. Represent Edwards Lifesciences in interactions with regulatory agencies, including responding to inquiries and participating in meetings and audits.
6. Stay up-to-date on industry trends and changes in regulations to proactively identify potential issues and recommend solutions.
7. Lead internal audits and support external audits to ensure compliance with regulatory requirements.
8. Support post-market surveillance activities, including adverse event reporting and product recalls.
9. Train and mentor junior regulatory affairs team members.
10. Maintain accurate and organized regulatory documentation and records.
11. Participate in the development and implementation of regulatory strategies for new and existing products.
12. Continuously improve and streamline regulatory processes to increase efficiency and effectiveness.
13. Act as a subject matter expert and provide guidance to cross-functional teams on regulatory matters.
14. Support the development and maintenance of regulatory policies, procedures, and SOPs.
15. Ensure timely and accurate reporting of regulatory metrics to management.

According to JobzMall, the average salary range for a Senior Specialist, Regulatory Affairs in Irvine, CA, USA is between $100,000 to $140,000 per year. However, this can vary depending on factors such as years of experience, specific job responsibilities, and the company's size and industry.

Edwards Lifesciences (NYSE: EW) is the global leader in the science of heart valves and hemodynamic monitoring.