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.
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
Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
Good problem-solving, organizational, analytical and critical thinking skills
Good written and verbal communication skills and interpersonal relationship skills
Ability to read, write and speak English required
Good knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
Good knowledge and understanding of global regulatory requirements for new products or product changes.
Good knowledge of new product development systems
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
Ability to build stable working relationships internally
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
