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 #02728 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 Regulatory Affairs Manager (Endoscopy) Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Direct and coordinate the activities of Endoscopy Regulatory Affairs Team, including direct supervision of specialists 2) Assist in establishing project priorities as well as allocating resources and workload 3) Provide technical guidance to the team during submission preparations and interaction with regulatory bodies 4) Review and edit submissions prepared by team members 5) Act as a core member on Manufacturing and Development Teams, providing regulatory affairs feedback and guidance throughout the product development cycle 6) Coordinate team inputs for submissions 7) Represent the Endoscopy Regulatory Affairs Team at management updates 8) Support and maintain quality initiatives as per company’s quality policy as well as assess ways to improve quality 9) Provide short-range strategy formulation along with implementing regulatory strategies for new and modified products 10) Develop and maintain positive relationships with device reviewers through communication (oral and written) regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review 11) Oversee preparation and submission of global regulatory applications (as appropriate) as well as internal regulatory file documentation 12) Review and sign-off product and manufacturing changes for compliance with applicable regulations 13) Review device labeling and advertising materials for compliance with submissions and applicable regulations 14) Analyze and recommend appropriate changes regarding device labeling and advertising materials Requirements 1) Bachelor's degree or equivalent work experience (scientific or technical discipline as well as professional certification preferred) 2) 6 – 8 years of regulatory affairs experience in the medical industry 3) Minimum 3 years of managerial/supervisory experience 4) Experience in medical devices 5) Sound knowledge of product development process and design control 6) Excellent understanding of global requirements 7) Superb technical knowledge of medical products 8) Sound understanding of relevant medical procedures, practice, terminology and products 9) Ability to effectively manage multiple projects 10) Superb organizational, leadership and interpersonal skills 11) Proficiency with Microsoft Office 12) 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.