We are seeking an experienced Senior Regulatory Affairs Specialist with a strong background in In Vitro Diagnostic (IVD) regulatory processes. This is your opportunity to join our dedicated team based in Waltham, Massachusetts and make significant contributions on both local and global levels.
As part of our company's commitment to advancing healthcare technologies through innovation, we require someone who can handle independent submissions efficiently while ensuring compliance across various markets including those regulated by FDA and Health Canada.
Key Responsibilities:
- Lead preparation for Global Submissions such as 510(k), focusing specifically on IVD-related products like blood analyzers.
- Handle Pre and Post marketing submissions
- Manage all aspects of IVDR/IVDD requirements effectively.
- Execute Independent Submission tasks with confidence and precision.
Skills Required:
- **In Vitro Diagnostic Regulatory Experience**: Expertise navigating regulations specific to diagnostics will be essential when liaising between development teams and regulatory bodies.
- **Blood Analyzers Knowledge**: A solid understanding related directly or indirectly around Blood Analyzer devices adds value during submission evaluations process due its specificity within industry standards guidelines set forth agencies worldwide.
Global Submissions Proficiency: You must possess sound skills working comprehensively international frameworks - particularly concerning strategies involving Food Drug Administration & Health Canada's stringent protocols which govern product approval cycles globally.
Independent Regulatory Submission and Authoring Experience
