Regulatory Affairs Associate, Global Compliance

Edwards Lifesciences Gruppe; California (MO); Hybrid; USD 59,000 - 83,000; Full time

Job summary

Edwards Lifesciences is seeking a Regulatory Affairs professional to support process improvements, coordinate global submissions, and maintain regulatory records. The role involves collaboration with cross-functional teams to ensure timely and compliant documentation for regulatory approvals.

The ideal candidate will have a science degree, experience in regulated industries, and strong project management and communication skills.

Qualifications

• Bachelor's Degree or equivalent work experience based on Edwards criteria.
• Bachelor's Degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry) or equivalent experience.
• Experience in a regulated industry and strong project management skills.

Responsibilities

• Develop routine Regulatory Affairs process improvements including system enhancements, training reports, and dashboards.
• Coordinate submissions deliverables, schedule and tracking of appendices and documents.
• Prepare compilation and publication of paper and electronic documentation for regulatory submissions.
• Maintain regulatory records and submission documentation in accordance with procedures.
• Prepare for regulatory inspections and audits and track RA plans and changes.

Skills

Attention to detail

Communication skills

Project management

Regulatory knowledge

MS Office skills

Education

Bachelor's degree or equivalent

Bachelor's degree in science

Tools

MS Office

Job description

Edwards Lifesciences is seeking a Regulatory Affairs professional to support process improvements, coordinate global submissions, and maintain regulatory records. The role involves collaboration with cross-functional teams to ensure timely and compliant documentation for regulatory approvals.

The ideal candidate will have a science degree, experience in regulated industries, and strong project management and communication skills.