Kathy Carpenter Email & Phone Number

Raymond, Nh, Us

Amesbury, Ma

♣ Manage daily operations of RQMIS office/consultancy♣ Review and edit regulatory, clinical and quality systems documentation, including 510(k)’s, QMS optimization, FDA audit and ISO 14385 certification preparation♣ Set up systems and procedures as required♣ Establish and maintain document control system including: clinical study files; regulatory submissions; quality systems; sales and Customer Relations support; finance and accounting administration; Calendar management of our busy office♣ Assist in training efforts♣ Participate in special projects as needed♣ Knowledge of the regulatory, clinical and/or quality systems as it pertains to medical devices and drugs ♣ Ability to produce business correspondence, proofread for grammar, spelling and punctuation with a high degree of accuracy♣ Ability to work on several projects simultaneously while continuously assessing company and/or departmental priorities