Overview Instrumentation Laboratory Our Passion. Your Results. Founded in 1959, Instrumentation Laboratory (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, patient blood management and Hemostasis testing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing medical professionals the most valuable and complete solutions to enhance patient care. As an integral part of Werfen, a global healthcare company dedicated to delivering the highest quality in vitro diagnostic products, IL is supported bysignificant resources, outstanding scientific expertise and a tremendous knowledge base. IL is headquartered in Bedford, MA, USA. Position Summary: Responsible to manage the pre-market regulatory activities required to maintain compliance to US FDA, Health Canada, European IVD Directive 98/79/EC as well as other country regulatory agencies. Pre-market: Leader on design teams for regulatory input, establishing regulatory worldwide strategy for release, and managing the US and Canadian submissions. Responsibilities Key Accountabilities: Manages the FDA 510(k) and Health Canada license submissions for new products and product modifications, coordinating deliverables with R&D and Marketing, interfacing with regulatory agencies and advising on strategies and requirements through registration. Participates as a design team member on new instrument and reagent development for the IL Bedford, IL Orangeburg and Biokit facilities, providing early input on analytical test requirements, acceptance criteria, user needs and regulatory submission strategy Develops the global regulatory strategy/plan for inclusion in the design file, advising the Company on the product's submission path, both domestically and internationally. Authors field communications, interfaces with IL departments to orchestrate release, prepares regulatory strategy, assembly necessary support documentation (e.g. corrective actions, risk assessments, labeling, etc.) and information (serial nos., lot nos., exp. dates, mfg. dates, quantities distributed, etc.) and administers all necessary activities to ensure that records are maintained in compliance with US, Canadian, EU and other international regulatory requirements. Performs literature searches. Advises and trains regarding impact of new regulations or trends. Reviews labeling and advertising/promotional claims (including Change Order reviews). Develops and maintain regulatory related procedures/policies. Other areas as needed to meet regulations Budget managed (if applicable): N/A Internal Networking/Key relationships: To be determined based on department needs Skills & Capabilities: Effective verbal and written communication in individual and group settings Must be detail oriented, have good organizational skills and be able to meet deadlines. Qualifications Min Knowledge & Experience required for the position: Requires a Bachelor degree, preferably in regulatory or science related areas Minimum of 5 years of experience in the medical device industry (in vitro diagnostics a plus) Knowledge of FDA Knowledge of FDA 21 CFR 820 and ISO standards, e.g. ISO 13485, etc., preferred International Mobility: Required: no Travel requirements: Some travel required If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Instrumentation Laboratory appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V Werfen is a global leader in in vitro diagnostics (IVD) in the specialities of Hemostasis, Acute Care Diagnostics and Autoimmunity. Our core business is dedicated to R&D, manufacturing and distribution of diagnostic systems for hospitals and clinical laboratories. Our other areas of expertise include Original Equipment Manufacturing, Clinical Software, Clinical Chemistry, Infusion Therapy, and Medical Devices and Scientific Instrumentation Distribution. We operate directly in over 30 countries and in more than 100 territories through distributors. In 2016, our turnover was approximately 1.2 billion euros and we had an average workforce of 4,400 people. Currently, we are over 5,000 employees.Salary Range: NAMinimum Qualification5 - 7 years
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