
Regulatory Affairs Specialist
4 days ago
About the Role:
We are seeking a skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring that our products comply with relevant regulations and guidelines.
Key Responsibilities:
- Support the product lifecycle through obsolescence by assessing changes made to the device post-launch to determine regulatory impact of changes to the current clearance.
- Evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications.
- Determine and communicate submission and approval requirements.
- Collaborate with cross-functional teams to develop and implement regulatory strategies.
- Develop and maintain knowledge of regulatory requirements, legislation, processes, and procedures.
Requirements:
- Bachelor's or Master's degree in Regulatory Affairs, Engineering, or equivalent discipline.
- 3-5 years of experience in an equivalent position within an R&D environment.
- Experience with post-market and change management is a distinct advantage.
- RAC Certification is preferred.
About Us:
We are a global leader in medical technologies, driven to make healthcare better. Our innovative products and services help improve patient and healthcare outcomes. We impact more than 150 million patients annually.
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