Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.    Job #02730 About our client Our client is a leading medical device company, which is focused in the development and commercialization of less invasive medical devices and procedures. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Principle Specialist, Corporate Regulatory Affairs Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead and manage activities to create and improve regulatory processes and systems 2) Provide technical guidance and regulatory training/mentoring to cross-functional teams 3) Lead process for development of regulatory metrics and project tracking 4) Act as company representative, developing and maintaining positive relationships with device regulators through oral and written communications 5) Develop and implement departmental and divisional policies and procedures 6) Act as a core member on Manufacturing and Development teams, providing regulatory feedback and guidance as well as coordinating team inputs for submissions 7) Support highly technical or major business initiatives, special projects or strategic initiatives 8) Represent Regulatory Affairs at management updates 9) Act as the Regulatory Representative for Management Review and CAPA teams Requirements 1) Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline 2) Professional certification(s) preferred 3) Minimum 6 years of regulatory affairs experience in the medical device industry 4) Track record of successful regulatory submission experience (global submission as well as FDA submission experience) 5) Experience in regulatory compliance and product development process and design control 6) Experience in medical devices preferred 7) Thorough understanding of global regulations 8) Strong technical knowledge of medical products 9) Good technical understanding of relevant procedures, practices and associated medical terminology 10) Strong knowledge of clinical trial strategy and study design as well as sponsor reporting requirements 11) Ability to effectively manage multiple projects 12) Excellent research and analytical skills 13) Ability to work independently with minimal supervision 14) Proficiency with Microsoft Office 15) Strong leadership, interpersonal and influencing skills 16) Excellent communication (written and oral), technical writing and editing skills
Home | Our Story | Domain Expertise | Clients | Career Opportunities | Community | Contact Us
© 2006 Sterling Life Sciences. All rights reserved. Terms of Agreement.