Global Regulatory Affairs Specialist Submissions

Edwards Lifesciences; Ciudad de México; On-site; MXN 350,000 - 550,000; Full time

Job summary

Edwards Lifesciences is seeking a Regulatory Affairs professional in Ciudad de México to help manage regulatory approvals and submissions for our medical device products. You will track timelines, contribute to regulatory strategy, and support cross-functional teams to ensure compliant product distribution.

The role requires experience in regulatory affairs, a scientific degree, and strong English communication skills, with opportunities to participate in process improvements and global

Qualifications

• Previous related experience in the Regulatory Affairs area required.
• Bachelor's Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry).
• Experience in preparing domestic and international product submissions preferred.
• English level: Intermediate to advanced.
• Good written and verbal communication skills and interpersonal relationships.

Responsibilities

• 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

Skills

Regulatory affairs

English proficiency

Communication skills

Team collaboration

Attention to detail

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Office Suite

Job description

Edwards Lifesciences is seeking a Regulatory Affairs professional in Ciudad de México to help manage regulatory approvals and submissions for our medical device products. You will track timelines, contribute to regulatory strategy, and support cross-functional teams to ensure compliant product distribution.

The role requires experience in regulatory affairs, a scientific degree, and strong English communication skills, with opportunities to participate in process improvements and global