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Senior Regulatory Affairs Specialist
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- Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory Affairs colleagues to drive timely and accurate submission development and applications.
- Plans and tracks specified product registration and renewal activity, ensuring alignment with portfolio priorities throughout the registration and renewal processes; manages expirations / renewals and planning for new applications.
- Bachelors degree or higher in Life Sciences, Engineering, or related disciplines.
- Minimum of 5 years plus experience in Regulatory Affairs.
- Proven knowledge of regulatory requirements and experience preparing international documents, such as STEDs, Design Dossier, and Technical Files and new products registration for Non-EU, Canada, LATAM, APAC (Australia, New Zealand, Korea, Taiwan, and Singapore), and EMEA.
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