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Health Care Attorney in Braintree, MA

Haemonetics Corporation Jun 21,2016 Location Braintree MA
This job is expired...

In-House

Attorney

Health Care

Litigation - Whistleblower - CFTC

Min 5 yrs required

Profile

Director, Diagnostics Regulatory and Clinical Affairs The candidate will work with the Diagnostics Portfolio team to design innovative pathways to broaden current promotional and advertising claims and gain regulatory approval of new claims on Haemonetics Diagnostic Products. A mixture of clinical trial establishment, Medical/ Clinical Experience and Regulatory Affairs execution through approval competencies will be required. Other responsibilities will include: create collaborative working relationships with US FDA and other global regulatory bodies; understand complex diagnostic equipment and disposable interactions with patients in the hemostasis management space in order to improve the standard of care in diagnosis and guidance of therapy; create a robust regulatory strategy that guides product development and launch throughout the product life cycle; create efficient, effective clinical trials and gain concurrence with regulators through the effective use of biostatistics that these trials will support expanded or new indications for IVD Products; create regulatory filings that receive swift review and approval by regulators with a minimum of questions through effective collaboration with Marketing, Development, Operations, Clinical teams and investigators, Investigational Review Boards, and Quality Assurance and clear, concise, accurate written applications; and understand the detailed operations of hospital and ambulatory surgical center hematology laboratories. Bachelor's Degree required. Medical Doctor, Statistics or Law degree preferred. Must have 5+ years of experience with Clinical trial design in a diagnostics setting and 5+ years experience with Regulatory filling in the diagnostics space.

Additional info

Ref: 161111169

Company info