Associate Specialist, Regulatory Affairs

About the role

Edwards Lifesciences' Regulatory Affairs teams help guide its innovative technologies through complex international regulatory environments, from design to production. This Associate Specialist position supports the regulatory submission of new products, product changes and renewals for the EMEA, Canada, Latin America and Middle East and Africa (EMEA CLA) region, working closely with internal stakeholders.

Key responsibilities

• Support the product life cycle management of new products, product changes and renewals submissions for product applications or country notifications in the EMEA CLA region.
• Track timelines, document milestones, develop regulatory strategy and align regulatory activities with operating plans and key operational drivers in assigned countries or areas.
• Develop routine regulatory process improvements such as system enhancements, training, reports and dashboards.
• Give stakeholders guidance and feedback on regulatory activities, strategies, contingency plans and registration requirements.
• Create regulatory submissions and playbooks under close supervision.
• Provide documentation or information needed for bids and tenders and take part in other projects as appropriate.

Required profile

• Bachelor's degree and relevant experience in regulatory affairs, compliance, medical/clinical affairs, data management, analytics or a related field.
• Fluent English; additional languages are a plus.
• Preferred: strong data management and analytical skills, accuracy and attention to detail, and a collaborative, proactive approach across teams and international stakeholders.

What we offer

• Competitive compensation and benefits package.
• Flexible working hours, with home office possible.
• Pension plan, risk life insurance and virtual medical clinic.
• Meal benefits, service awards and enhanced sick leave.
• Flexible benefit plan (cafeteria), employee stock purchase program and employee assistance program.
• Wellness program including onsite gym, yoga, pilates or SM System classes, massages, fresh fruit, healthy lifestyle workshops and educational events.