International Regulatory Specialist
4 days ago
Regulatory Affairs at Edwards Lifesciences
We are committed to delivering innovative technologies through complex international regulatory environments. Our Regulatory Affairs teams work closely with external government and regulatory authorities, as well as diverse internal stakeholders, to ensure our products reach clinicians and improve patients' lives.
About the Position
- This role requires a highly skilled Regulatory Affairs professional to lead the implementation of various regulatory process improvement projects and ensure compliance with international regulations.
- The successful candidate will be responsible for maintaining awareness of regional regulatory changes and collaborating with the regulatory intelligence team to identify and implement solutions that meet requirements and ensure SOP compliance.
- This position involves proposing strategies and contingency planning for JAPAC regulatory requirements, facilitating teleconferences and meetings with key stakeholders, and executing and providing recommendations on process improvement/remediation projects to expedite new product launches.
Key Requirements
- Bachelor's degree in a relevant field (3-5+ years' experience in the medical device, biotech, or pharmaceutical industry).
- Strong project management, problem-solving, and organizational skills; excellent documentation, communication, and interpersonal relationship skills.
- Ability to speak, read, and write English fluently; reading/speaking Japanese is a plus.
- Extensive understanding of principles, theories, and concepts relevant to managing complex project plans, with strong leadership skills and ability to influence change.
- Experience in facilitating change, collaboration with management and functional stakeholders, and working within a regulated environment.
- Strict attention to detail, ability to manage competing priorities in a fast-paced environment, and willingness to travel up to 20% of the time within Asia Pacific countries and global manufacturing sites.
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