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 #02731 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 Senior Regulatory Affairs Specialist Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Prepare submissions to obtain and maintain global regulatory approvals for clinical research and commercial distribution of endoscopy products 2) Provide technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams 3) Act as a company representative for regulatory agency reviewers 4) Develop and maintain positive relationships with regulatory agency reviewers through communications (oral and written) regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review 5) Develop and implement regulatory strategies for new and modified products 6) Provide regulatory guidance and direction as a core member on Manufacturing and Development teams throughout the product development cycle 7) Identify/Coordinate cross-functional deliverables for submissions 8) Review and approve device labeling and advertising materials for compliance with global regulations 9) Analyze and recommend appropriate changes regarding device labeling and advertising materials 10) Review and approve product and manufacturing changes for compliance with applicable regulations 11) Develop and implement departmental as well as divisional policies and procedures 12) Support highly technical or major business segment product lines, special projects or strategic initiatives Requirements 1) Bachelor’s degree or equivalent work experience (scientific or technical discipline preferred) 2) Professional certification(s) preferred 3) 5 – 8 years of Regulatory Affairs experience in the medical industry 4) Experience in Medical Device (International experience a plus) 5) Demonstrated success in management of regulatory submissions activities 6) In-depth understanding of global regulations 7) Superb technical knowledge of medical products 8) Excellent technical understanding of relevant procedures, practices, and associated medical terminology 9) In-depth knowledge of clinical trial strategy and study design as well as sponsor reporting requirements 10) Excellent knowledge of product development process and design control 11) Ability to manage multiple projects 12) Excellent research and analytical skills 13) Strong leadership, interpersonal and influencing skills 14) Proficiency with Microsoft Office 15) 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.