Director or Senior Director
Company: Beaver-Visitec International, Inc.
Posted on: September 12, 2020
We're looking for a candidate to fill this position in an
This position will be responsible for developing a strategic
clinical and regulatory plan through pivotal IDE trials, developing
strong relationships and obtaining regulatory approvals from the
FDA and other global regulatory agencies. The Director or Senior
Director will develop strategic direction and priorities for
clinical development, working with R&D, Marketing and Quality
leadership to define clinical development projects including
objectives, work plans, milestones and deliverables. This
role will Work with internal and external parties to design and
execute pivotal clinical trials in line with Good Clinical
Practice, company SOPs, FDA guidelines, and ISO standards (as
applicable), including prioritizing indications, choosing
appropriate populations and endpoints, planning and executing
statistical analysis, and identifying risks. Provide overall
clinical site management from qualification/start-up to closeout,
including training, site initiation, CRF review, protocol and
regulatory compliance, device accountability, and visit reports.
They would develop and implement a regulatory strategy and related
activities needed to demonstrate safety and effectiveness and to
reach premarket notification and/or approval. They will
actively support the regulatory submission process, acting as a
point of contact for FDA or other regulatory bodies. The Director
or Senior Director will be expected to ensure regulatory compliance
of company's devices with the FDA and other applicable regulatory
jurisdictions, identifying and assessing regulatory risks.
Requirements: BS or higher in a technical or clinical discipline
(engineering, biology/life sciences) Preferred: Master's degree in
technical or clinical discipline. Ophthalmology background. 10+
years clinical research exp., in a medical device setting (prefer
Experience within ophthalmology. ) Experience with Class I, II and
III medical devices. Previous experience in a pivotal IDE trial.
Demonstrated experience with major regulatory submissions - PMA,
510(k), etc. Excellent analytical skills required; (some formal
training in statistics is preferred). Positive, self-motivated,
detailed, and hands-on, with the ability to work independently as
well as collaboratively across company Innovation Units. Sitting
for long periods of time; standing; squatting; reaching; computer
work (typing), phone usage; filing; lift to 20lbs. unassisted.
Keywords: Beaver-Visitec International, Inc., Waltham , Director or Senior Director, Other , Waltham, Massachusetts
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