LeMaitre Vascular seeks an outstanding leader in the medical device field to join our winning
team as the Director of Regulatory Affairs, Quality Assurance and Clinical Affairs. This
individual will be responsible for all world wide regulatory filings and maintenance of
products or markets, as well as quality, quality systems and monitoring of all clinical trials.
Reporting to the Chief Executive Officer, this individual will also be responsible for
overseeing numerous direct reports.

Responsibilities:

Candidate will be responsible for developing and implementing regulatory strategies and for
developing the content and format for all regulatory submissions. Candidate will keep abreast
of policies and practices issued by Federal and international regulatory agencies in order to
negotiate directly with regulatory authorities regarding company filings and to advise
corporate personnel regarding any developments or potential areas of regulatory concern.
Candidate will confer with engineers and material and component vendors with respect to quality
assurance of products to rectify any problems. Candidate will also serve as an integral part of
the management team by analyzing, evaluating and presenting information concerning production
capabilities, manufacturing problems, economic trends, regulatory developments and the
design/development of new products in order to help develop and attain departmental and
organizational goals.

Requirements:

Candidate must have a Bachelor�s degree (Master�s preferred in Business Administration or Life
Sciences) and 5-10 years of experience in the medical device field, with at least 3-7 years of
experience in Regulatory Affairs, Quality Assurance and Clinical Affairs. Candidate must
demonstrate a proven record of effective interactions with the FDA, and must possess excellent
supervisory, communication and project management skills.

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