Regulatory Affairs Specialist

Job Summary This position will determine the current regulatory requirements and strategies for Terumo’s devices and projects and define information and actions necessary to meet requirements. Determining strategy and requirements within the position will vary in complexity based on scope and different regulatory markets. This position will prepare documents and/or submissions required to obtain clearance or approval from government agencies for commercial distribution of products worldwide. Serves as a liaison between Regulatory Agencies and Terumo Medical Corporation. Mistakes made in this area can be very costly, i.e., delays in product clearance or approval withdrawal of product from the marketplace, or enforcement of fines. Any of the above would have a major impact on the corporation. Associate is responsible to follow requirements of applicable national and international regulations. Analyze data received and prepare documentation for submission for the purpose of obtaining clearance and or approval for product distribution. Participates on product design teams and verifies compliance with design control requirements and procedures. Determine appropriate regulatory requirements and strategies for new product development projects including both domestic and foreign activities and provide regulatory consultation to other internal and external entities. Maintain documentation and a historical record for projects and provide management with updated product status. Maintains current knowledge of Federal USA, Canadian, MDR and other International regulations pertaining to legal distribution of medical products. Stays abreast of Regulatory Agency updates including new policies and guidance’s. Interact with production division, federal agencies, industry organizations, interdepartmentally and external departments at all levels with guidance. Assists external customers by supplying materials and documentation for US and International product registrations as well as certification of appropriate US commercialization status. Must make a proactive contribution to the overall Regulatory affairs department growth. Participates in project performance team meetings on behalf of the business unit in order to provide ideas, methods or processes for unit/company performance improvement. Develop regulatory strategies for new products with the guidance of Regulatory Management Performs other job related duties as assigned. Knowledge, Skills and Abilities (KSA) Strong organizational skills and time management skills Knowledge of GLP/GMP requirements Strong written and oral communication skills Knowledge of FDA, EU, MHLW, TGA and other International requirements Knowledge of product labeling requirements and standards Advanced ability for independent work, teamwork, and decision making Ability to make correct decisions based on interpretations of federal laws, which in many instances are very general in nature to accommodate a variety of industries. These interpretations are used for every aspect of the regulatory discipline from submissions to labeling issues. Ability to analyze data received and prepare documentation for submissions for the purpose of obtaining clearance and or approval for product distribution. Qualifications/ Background Experiences Requires a minimum of a 4-year degree in engineering, life sciences, or similar discipline and one year of relevant experience or combination of equivalent education, background, experience and training Experience in a medical device quality assurance environment preferred Experience with 510(k)/IDE/PMA device submissions and/or other worldwide submissions and clearances preferred. Experience with FDA requirements, guidance documents, Medical Device Directive, Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards preferred. It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Pay range: $61,440 - 84,480 #J-18808-Ljbffr Terumo Cardiovascular Group