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.
How you’ll make an impact:
- Plan registration activities with accountability for successful completion within agreed timeline in order to deliver licenses and to ensure regulatory compliance and market access
- Provide direction and guidance to other team members (if any) to execute tactical registration initiatives
- Evaluate registration, labeling, product documentation and promotional materials and build process improvements and course correction/course alignment opportunities
- Analyze local regulatory trends and market intelligence information; advise and make recommendations to International 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 IMDRF or local industry committees to gain market intelligence information
- Develop solutions on regulatory issues and present to both internal and external parties
- Analyze information on product recalls from field corrective action team (EW global quality team) and provide reports to government
- Other incidental duties
What you'll need (Required):
- Bachelor's Degree or equivalent in related field , 12 years of previous related experience required or
- Master's Degree or equivalent in related field , 8 years of previous related experience required
- Experience in high risk medical device (Class 4)
- Experience with K-GMP audit
- 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
What else we look for (Preferred):
- Proven successful project management skills
- Proven expertise in both Microsoft Office Suite, including advanced Word, Excel and government regulatory systems
- Extensive knowledge of regulatory affairs within the organization while contributing to the development of new concepts, techniques, and standards
- Extensive understanding of related aspects of product lifecycle processes and Edwards Ignite system 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
- Represents leadership on sections of projects within a specific area interfacing with country management teams (e.g. Business Unit head, Quality head, Ops head, Finance head)
- 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