Regulatory Affairs Specialist II LinkedIn Twitter Email Message Share Why Join Bracco Medical Technologies? At Bracco Medical Technologies, every employee has an impact on our Mission to empower lifesaving decisions. We create medical devices that give healthcare providers the insights they need to confidently and safely diagnose patients. Our unique line of products includes Intravascular Ultrasound (IVUS), Fractional Flow Reserve (FFR), Cardiovascular Imaging contrast delivery (CVi), and CT and MRI contrast delivery systems. Position Description Position Summary: As a member of the Regulatory Operations team, the Regulatory Affairs Specialist II completes regulatory submissions related to market expansions as well as sustaining product line international regulatory renewal activities. This role will also include administrative functions such as maintaining databases (ex. Regulatory Information Management System, GUDID, EUDAMED), maintaining a filing and documentation system, coordinating paperwork associated with contracts and processing product requests in SAP. This individual represents Bracco Medical Technologies (BMT) Regulatory with global regulators on submission reviews/approvals and ensures compliance with required regulations and established corporate standards. Primary Duties & Responsibilities: * Understand current and evolving worldwide regulatory submission requirements for regions including, but not limited to Latin America, Asia Pacific, and Europe. Advise regulatory submission teams regarding such requirements. * Support assigned regulatory projects and provide direction to project teams. * Collaborate on application of external standards for assigned projects as required. * Maintain regulatory documentation to ensure availability for audits and preparation of submission packages. * Establish and maintain good relationships with the Distributors, Authorized Representatives, Competent Authorities and other official representatives of trade entities. * Update and maintain templates and SOPs for regulatory submissions. * Aid Regulatory Affairs team in activities such as cover letter and form preparations associated with regulatory submissions. * Facilitate payments needed for submissions, establishment registrations, export certificates and other regulatory activities. * Assist with review of device labeling for compliance with submissions and applicable regulations; analyze and recommend appropriate changes. * Support audits and participate in CAPAs, process improvements, and other special projects as needed. * Collaborate effectively with cross-functional teams to support new product registrations, renewals, product changes and market expansion activities. Qualifications (Knowledge, Skills & Abilities): Minimum: * High School Diploma or GED equivalent is required. * Bachelor's degree plus 2-4 years experience in Regulatory Affairs. In lieu of degree, 4+ years of experience in Regulatory Affairs will be considered. * Minimum of 2 years of experience in Medical Device or related industry. * Working knowledge with quality systems regulations and guidelines. * Understanding of international submission requirements and regulatory framework, including how to comply with international standards and regulations. * Must have the ability to develop clear, concise and timely oral and written reports, plus communicate tactfully with all levels of personnel. * Working knowledge of medical devices, procedures and terminology. * Proficiency with MS Office. * Experience establishing and managing plans and timelines to achieve desired outcomes. * Ability to solve problems through the application of critical thinking skills. * Effective written and verbal communication skills, technical writing and editing skills. * Ability to convey technical materials concisely to audiences of varying degrees of familiarity. * Must be able to work in fast-paced, growing environment under management direction. Preferred: * 4+ yrs of experienc in Medical Device industry or related field * Bachelor's degree * International market submission experience * High level of planning and organizational skills * Effective research and analytical skills * RAC certification * SAP experience * RIMS database experience Other: * Requires intense concentration to accurately assess compliance to applicable regulations for medical device manufacturers. * The work is detail-oriented, often with multiple priorities * The environment is deadline sensitive, with frequent high-pressure situations. * Travel requirements are minimal. Job Location 7905 Fuller Road, Eden Prairie, Minnesota Tracking Code 1319-432 ACIST Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.