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Job #03187

About our client Our client is a leading medical device company based in Hudson, New Hampshire. They specialize in developing technologies for the treatment of cardiovascular diseases, such as coronary stents and state-of-the-art hernia repair. They have offices in Australia and the Netherlands, and boast 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 Specialist 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 reviewing 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 quality systems regulations, 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 related experience in regulatory affairs in a GLP/GMP environment 3) Ability to multi-task and handle a number of projects simultaneously, in a fast-paced environment 4) Proficiency in regulatory planning and strategy (510(k)/IDE/PME) submissions 5) Ability to represent Regulatory Affairs to other departments 6) Ability to produce high-quality work with excellent attention to detail