Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.

How you´ll make an impact:
- Completes and maintains regulatory approvals and clearances of assigned products.
- Create regulatory submissions/playbook under close supervision, exercising judgment to protect proprietary information).
- Track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize regulatory activities with operating plans as well as ensuring alignment with KOD in assigned countries/area of work (e.g., country clusters, COE, Canada)
- Develop routine Regulatory Affairs process improvement initiatives including system enhancements, training, reports and/or dashboards.




- Execute all RA activities in Edwards systems to ensure compliant product distribution.
- Prepare documents for submissions, including assuring the appropriate forms for all appropriate regulatory bodies
- Participate in providing guidance and feedback to stakeholders on regulatory activities (e.g., strategies, contingency plans, registration requirement)
- Participate in projects as appropriate
- Other incidental duties assigned by Leadership

What you will need:
- Previous related experience in the Regulatory Affairs area required.
- Bachelor's Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry, among others)
- Experience in preparing domestic and international product submissions preferred
- Other: in Coursework, seminars, and/or other formal government and/or trade association training Experience in preparing domestic and international product submissions preferr

📌 Associate Specialist Regulatory Affairs (Ciudad de México)
🏢 Edwards Lifesciences
📍 Ciudad de México