Regulatory Affairs Specialist

Completes and maintains regulatory approvals and clearances of assigned products.

**Key Responsibilities**:

- Create regulatory submissions/, exercising judgment to protect proprietary information) for finalization and submission; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize regulatory activities with operating plans as well as ensuring alignment in assigned countries/area of work (e.g., country clusters, COE, Colombia and indirect markets)

Or

Identify and develop moderately complex Regulatory Affairs process improvement initiatives including system enhancements, training, reports and/or dashboards including executing all RA activites in Edwards systems to ensure compliant product distribution.
- Identify trends, assess impact, analyze alternatives and recommend action plans
- Participate in providing guidance and feedback to stakeholders on regulatory activities (e.g., strategies, contingency plans, registration requirement) including assessing impact to appropriate regulations
- Prepare documents for submissions, including assuring the appropriate forms for all appropriate regulatory bodies
- Incidental: Other duties as assigned by Management

**Education and Experience**:
Bachelor's Degree in related field, 3 years of previous related experience Required
in scientific discipline (e.g., Biology, Microbiology, Chemistry) Preferred

**Other**: Coursework, seminars, and/or other formal government and/or trade association training Preferred
Experience in preparing domestic and international product submissions Preferred

**Additional Skills**:

- Good medical writing skills
- Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
- Good problem-solving, decision-making, organizational, analytical and critical thinking skills
- Good written and verbal communication skills and interpersonal relationship skills
- Ability to read, write and speak English required;
- Knowledge and understanding of global regulatory requirements for new products or product changes.
- Solid 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 inter-departmental teams and representing the organization on specific projects
- Ability to build productive internal/external working relationships
- 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

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

COVID Vaccination Requirement

**For United States Applicants Only**:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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