Regulatory Affairs Specialist managing regulatory processes for TidalSense medical devices in various global markets. Preparing submissions and ensuring compliance in fast - paced healthcare environment.
About the role
- Senior Regulatory Affairs Specialist advising on regulatory strategy for medical devices. Ensures compliance and supports regulatory submissions for medical technologies.
Responsibilities
- Advise regulatory strategy for company’s devices
- Ensure compliance to regulatory requirements for assigned regions
- Translate complex regulatory requirements into practical plans
- Interact with regulatory agencies and senior leadership
- Represent Regulatory for product development
- Ensure submissions and registrations are authored and submitted on time
- Guide teams on regulatory issues
- Maintain US FDA establishment registrations and device listing
Requirements
- Bachelor’s degree in a scientific or regulatory discipline
- 8 years' experience in the medical device industry; or equivalent work experience
- Minimum 5 years' experience in Regulatory Affairs role
- Experience interpreting FDA and international guidelines and regulations
- History of successful US FDA 510(k) clearances for Class II devices and interactions with regulators
- Experience with EU MDR, Health Canada, and Australia TGA regulatory submissions
- Experience with international registrations
- Proven track record of navigating swiftly and efficiently through the regulatory process as part of a team
Benefits
- Health insurance
- Corporate bonus
- Equity plans
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