Manager, Regulatory Affairs
5 months ago
**Key Responsibilities**:
- Plan registration and labeling strategies and activities within agreed timeline in order to deliver licenses and to ensure regulatory compliance.
- Identify and evaluate registration and labeling, and build process improvements and course correction/course alignment opportunities.
- Provide direction and guidance to other team members (if any) to execute tactical registration and labeling initiatives.
- Analyze local regulatory trends and market intelligence information; advise and make recommendations to BU RA team on the potential high impact risks and change implementation.
- Build and maintain relationships with local authorities through workshop or forum hosting and through AMCHAM, AdvaMed or local industry committees to gain market intelligence information.
- Develop solutions on regulatory issues and present to both internal and external parties.
- Other incidental duties.
**Education and Experience**:
- Bachelor's Degree in in related field, 8 years years experience of previous related experience Required or
- Master's Degree or equivalent in in related field, 6 years years experience of previous related experience Required
- Other: Experience working in a healthcare company Required
**Additional Skills**:
- Proven successful project management skills.
- Proven expertise in both Microsoft Office Suite and government regulatory systems.
- Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
- Fluent in reading, writing and speaking English.
- Expert knowledge of regulatory affairs within the organization while contributing to the development of new concepts, techniques, and standards.
- Expert understanding of related aspects of product lifecycle processes and government regulatory systems.
- Extensive knowledge of Edwards products.
- Knowledge of healthcare industry.
- Strict attention to detail.
- Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
- Ability to manage competing priorities in a fast paced environment.
- Consult in project setting within specific sections of regulatory affairs area.
- Provides leadership to outsourcing partners of regulatory affairs consulting companies (e.g. on registration, labeling) on special projects.
- 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 18,500 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.
**Know your Rights**: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice
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