Regulatory Affairs Specialist, IVD Compliance Expert
3 weeks ago
Role Overview:
We are seeking a highly skilled Regulatory Affairs Specialist to join our Global Regulatory Affairs team. This individual will play a key role in coordinating and tracking International submissions, product change notifications, product release and licensing requirements, and registration of IVD products for Agilent's extensive IVD portfolio.
Key Responsibilities:
- Support IVDR regulatory activities, including design history file review, IVDR strategy drafting, and Requirements documentation preparation
- Implement tools for accurate tracking of product changes
- Collaborate with Global Regulatory Affairs ensuring regulatory assessments of changes are sought, obtained, and documented
- Collaborate with project team representatives for accurate tracking on project deliverables
- Oversight of IVD registrations and renewals
- Ensure timely registration of IVD products and their renewals
Requirements:
- A university degree in a relevant field such as Life-Science/Engineering/Law etc.
- Significant regulatory experience with a solid understanding of IVD/medical device regulations and registration requirements
- Ability to interpret regulations and standards in relation to specific products
- Excellent interpersonal and communication skills in English
What We Offer:
- An independent job in collaboration with good colleagues, in a growth-oriented organization
- A true commitment to work/life balance
- An opportunity to learn and grow in the field of Regulatory Affairs
- A competitive salary of approximately $85,000 per year, plus benefits, stock purchase plan, life insurance, pension, healthcare, employee assistance program, holiday, company activities
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