A Heritage of Precision, Innovation and Quality
BVI is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.
BVI is currently seeking a Director or Senior Director, Clinical & Regulatory Affairs. As a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.
The Director or Senior Director of Clinical and Regulatory Affairs will lead the strategic direction and operational aspects of clinical development, global regulatory compliance and submissions for BVI Class I, II and III medical devices. The incumbent functions as the regulatory subject matter expert for PMA filings and Clinical Trials. 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, BVI 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 BVI’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 BVI Innovation Units.
Sitting for long periods of time; standing; squatting; reaching; computer work (typing), phone usage; filing; lift to 20lbs. unassisted.
BVI is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.