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Senior Regulatory Affairs Manager

Location: Bedford, Massachusetts, United States
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Our client is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing.  They are passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

The Right Talent:

Bachelors degree, preferably in regulatory or science related areas.

Minimum of 5 years of management experience in the medical device or IVD industry.

Knowledge of FDA 21 CFR 803, 806, 820, Health Canada Medical Device Regulation, European IVD Directive 98/79/EC and European IVD Regulation (EU) 217/746, MDSAP Companion Document and ISO 13485, preferred.

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