This person will be responsible for all regulatory activity, including 510(k), PMA, and IDE filings, label/advertising/promotional review, and other regulatory compliance activities. Reports to the CEO and, working with the CEO and outside experts, will develop and implement regulatory strategies that will ensure earliest possible introduction of product(s) into domestic and international markets. The person will interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications. Develop and maintain strong and effective relations with internal/external personnel.
REQUIREMENTS * Develop regulatory assessments and strategies in support of the company's business activities. * Coordinate clinical studies of new and/or modified devices and/or claim expansion activities. * Prepare regulatory submissions (510(k), PMA) to secure FDA marketing clearance. * Prepare Technical Files and Design Dossiers in compliance with the European Medical Device Directives with interaction with Notified Bodies. * Prepare / coordinate regulatory submissions for all areas of the world. * Educate the organization on and review and approve of regulatory aspects of product labeling. Monitor changes to domestic and international regulations and standards. * Insure company compliance to all applicable regulations and standards. * Assess and maintain the company's Quality System.
QUALIFICATIONS > Bachelor's degree (BS) in a science or technical arena. > Ten (10) years of experience in the Medical Device Industry. > Five (5) years experience in developing and leading regulatory submissions/ registrations/ technical files, etc, required. > Strong working knowledge of QSRs and other applicable FDA regulations; specifically Design Controls, required. > One (1) -3 years experience in conducting / monitoring clinical trials preferred. > Experience working in an FDA-regulated environment for software controlled electromechanical devices or sterile disposables, required. > Experience with ISO9001, ISO 13485, CE marking requirements, and MDD required. > Experience with General Principles of Software Validation and ISO14071, and Risk Management ISO14971, required. > Demonstrated high performance orientation, detail orientation, and market knowledge, required. > Excellent written, listening, and verbal communication skills required.
COMPENSATION & BENEFITS Company offers competitive salary and benefits, including a company-funded SEP-IRA and stock options.
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