Regulatory Affairs Specialist 2

Hologic is seeking a Regulatory Affairs Specialist 2 responsible for international regulatory activities associated with Notified Body in EU, and other international regulatory agencies. This position requires a person with commitment to excellence, and ability to work in a fast-paced, technically skilled, team setting. Essential Duties and Responsibilities The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Prepare and maintain international submission dossiers Prepare, compile and publish electronic pre-market and post-market regulatory submissions Compile Technical Documentations for IVD medical devices to support EU CE-Mark Interact with business partners to support ROW submissions for IVD medical devices (Asia Pacific, Latin America, Europe, the Middle East and Africa, Canada etc.). Monitor progress on key project deliverables and provide status updates to management on a regular basis. Support on-market regulatory activities and new product development core teams as assigned by management Manage relationships with international customers (e.g., regulatory agencies, distributors, etc.) Demonstrate in-depth understanding of advanced technical/scientific principles related to MDR / IVD reagent chemistry, laboratory automation, and software components of MDR / IVD medical devices Communicate regulations to technical functions within the company Qualifications Education & Experience Bachelor's Degree required in the life sciences or engineering with a minimum of 3 years direct experience in Regulatory Affairs (within an MDR / IVD industry preferred); or Master’s Degree and/or RAC with a minimum of 1 year direct experience in Regulatory Affairs within the MDR / IVD Industry International RA experience required. Skills Demonstrated ability to coordinate complex projects Solid working knowledge of the US Regulations and European IVD and medical device regulations Experience with International submissions and IVDs highly desired Capacity to communicate regulations to technical functions within the company Experience with document control systems such as Agile and Oracle Medical device software submission and validation experience desirable Strong oral and written communication skills with ability to write detailed information for submissions Bilingual abilities are a plus Good analytical and problem solving skills Proficient ability to read, analyze and interpret technical documents, professional journals, technical procedures and government regulations Strong interpersonal skills including the ability to interact with all levels of the company Ability to manage relationships with international customers (e.g., regulatory agencies, distributors, etc.)

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