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 #02914 About our client Our client is a leading medical device company based in the Northeast. They specialize in developing technologies for the treatment of cardiovascular diseases, such as coronary stents and state-of-the-art hernia repair. The company has offices in Australia and The Netherlands and boasts a demand of over 2 million sterile medical products to over 60 countries every year. With emphasis placed on personal development of employees, this is a great opportunity for the right candidate! Position Location Regulatory Affairs Manager/Associate Hudson, New Hampshire Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee internal, domestic and international compliance activities 2) Prepare regulatory strategy/plans and requirements 3) Participate in the review and disposition of labeling, promotional material and product modifications 4) Prepare worldwide regulatory submissions/registrations 5) Support Engineering changes through RA/QA practices by documenting the changes in compliance with the Quality Systems Regulations, the Medical Device Directives, CMDR and other international regulations 6) Prepare documentation and coordinate activities related to PMAs, 510ks and IDEs 7) Participate in cross-functional departmental team projects and product development activities/meetings 8) Provide interface between regulatory agencies such as the FDA and the European Notified Body 9) Oversee FDA/ISO/MDD/CMDR compliance documentation 10) Perform other related duties (as required) Requirements 1) Bachelor’s degree 2) Minimum 3 years of directly related experience in Regulatory Affairs (GLP/GMP environment) 3) Ability to multi-task and handle a number of projects simultaneously in a fast- paced environment 4) Proficient in regulatory planning and strategy and 510(k)/IDE/PME submissions 5) Ability to represent Regulatory Affairs to other departments 6) Keen attention to detail 7) Ability to produce high-quality work
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