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Job #02927

About our client Our client is a successful division of a world-leading medical device company that has developed a reputation for successfully bringing complex products to market in a variety of therapeutic areas. The company has some of the strongest financial indicators in the industry, an experienced management team and a robust pipeline. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Director of Regulatory Affairs San Jose, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide regulatory leadership to the various business units 2) Serve as a member of the Worldwide Regulatory Leadership Team 3) Direct the regulatory affairs activities within the business units (including interactions between the company and agents of the US FDA and health ministries outside of the US) as required 4) Contribute to development of strategic and operational plans through sound assessments of regulatory pathways and risks as well as sound regulatory programs 5) Ensure functional excellence in regulatory activities to achieve rapid worldwide clearance/approval/registration/licensure of products with desired claims 6) Work (actively) in external efforts to develop policies, guidance and standards of strategic importance to the company 7) Facilitate the resolution of complex problems requiring exercise of foresight and intellectual analytical skills 8) Develop budgets and plans for the Regulatory Affairs Department 9) Represent Regulatory Affairs in division business and leadership team interactions 10) Communicate new developments in worldwide regulations affecting division products to the business teams, RA Department and other groups Requirements 1) Bachelor’s degree (Life Sciences field preferred) 2) 7 years of experience in regulatory affairs and 2 years of supervisory or managerial experience 3) Regulatory Affairs certification preferred 4) Experience in regulatory affairs in a healthcare, pharmaceutical or medical device company 5) Experience in IVD products and FDA's OIVD (flow cytometry, immunoassay, or hematology preferred) 6) Experience in project management, product development processes and design control 7) Excellent organizational and planning skills 8) Good analytical and problem-solving skills 9) Excellent communication skills (written and verbal) 10) Good interpersonal skills 11) Proficient in computers (MS Word, Excel and PowerPoint) 12) Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices 13) Ability to be effective in complex projects with ambiguity and/or rapid change 14) Ability to multi-task as well as prioritize and schedule work to meet business needs 15) Ability to interact effectively with technical personnel (scientific and legal) 16) Action-oriented individual with a focused urgency in driving results 17) Ability to work in a team as well as influence and lead others 18) Detail-orientated with emphasis on accuracy and completeness