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Job #02929

About our client Our client is a privately owned medical device company that is focused on the treatment of vascular disease. The company has an experienced CEO and board, an exciting product candidate and a team that is committed to the highest standards of integrity and to improving the lives of patients and their families. Position Location Regulatory Affairs Manager/Associate Kirkland, Washington Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead and work closely with Regulatory and other senior management to develop company-wide programs and processes for strategic planning as well as implementing submissions for new and modified products 2) Develop effective regulatory strategies to meet business objectives 3) Educate, train, advise and coach regulatory and other company professionals on the regulations, procedures and processes relevant to product registration submissions 4) Liaise with internal personnel and external regulatory bodies to ensure appropriate input into regulatory strategies 5) Develop and drive improvements (to overall QMS) documentation to provide clear flow down of regulations 6) Work with Quality to ensure appropriate auditing for compliance and consistency 7) Identify, assess and proactively manage regulatory risk 8) Lead and support continuous improvement activities within areas of assigned duties 9) Collect, summarize and evaluate performance metrics to identify program weaknesses as well as drive improvements in procedures 10) Provide overall leadership to the Regulatory compliance aspect of the business 11) Lead a strong global Regulatory Team 12) Oversee the investigation and communication of product complaints 13) Act as a major contributor to the growth and success of the company 14) Participate in development of key corporate objectives 15) Ensure smooth interface of quality and regulatory functions Requirements 1) Bachelor’s degree (Advanced degree preferred) 2) Minimum 3 – 5 years of experience in regulatory affairs in the medical device industry 3) Medical device regulatory submissions experience 4) Knowledge of and experience in applying pre-market approval/product registration requirements (IDEs, 510ks, PMAs, etc.) 5) Experience in applying adverse event reporting laws, regulations, guidance and policies 6) Knowledge of applying recall requirements 7) Supervisory/managerial experience or ability to lead cross-functional, cross-business teams 8) Experience in working with regulatory agencies such as the FDA 9) Excellent communication skills (using media like verbal, written, presentation and spreadsheet software, etc.) 10) Ability to set priorities for teams 11) Team player