Director of Clinical and Regulatory Affairs
at Rhythmia Medical in Burlington, MA
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Apr 25, 2013
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Overview
Rhythmia Medical, a venture-backed company designing an innovative system to treat cardiac arrhythmias, is targeting one of the fastest growing fields in medical devices. The system includes state of the art signal processing, 3D imaging and catheter fabrication technologies. We are extremely selective in our hiring and employ a small team of super talented individuals whose aim is to have a major impact on developing a breakthrough life-saving technology.
We are looking for an exceptionally bright Director of Clinical and Regulatory Affairs, with demonstrated outstanding performance in previous organizations. This is a high impact position taking a leading role in the development and implementation of clinical and regulatory strategies and submissions, in interfacing with physicians and hospitals, and providing input into product development teams and management.
We are looking for an exceptionally bright Director of Clinical and Regulatory Affairs, with demonstrated outstanding performance in previous organizations. This is a high impact position taking a leading role in the development and implementation of clinical and regulatory strategies and submissions, in interfacing with physicians and hospitals, and providing input into product development teams and management.
Responsibilities
Help lead the Clinical and Regulatory efforts at Rhythmia
Responsible for coordination/execution of all operational aspects of pre-clinical and clinical studies, including study protocols, data collection, and summaries.
Ensure that studies conform to regulatory requirements.
Interface with physicians / clinical investigators, regulatory agencies and internal staff.
Provide regulatory advice and guidance to product/project teams and other functional groups.
Direct medical writing activities.
Ensure that the content, organization and overall quality of all regulatory documentation are adequate and sufficient to meet regulatory requirements.
Act as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
Give frequent oral and written presentations to internal and external audiences on the medical and clinical aspects of the product.
Skills
MD or PhD or other life science degree with clinical background. All medical specialties will be considered, with a particular emphasis on cardiology
5+ years clinical and/or regulatory affairs experience in early to mid stage medical device company – preferably in a cardiology or electrophysiology field
Experience in developing research protocols and clinical research publications
Experience with FDA submissions is a plus
Must have strong writing, project management and communication skills
Ability to communicate technical ideas clearly to both technical and not technical staff.
Demonstrated technical writing ability with good organizational skills
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