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Senior Regulatory Affairs Specialist Location: Minneapolis, MN, US Job Family: Country/Region: United States The Senior Regulatory Affairs Specialist is responsible for complaint assessment and complaint reporting. This position will also prepare, monitor and communicate status of regulatory submissions and perform duties related to regulatory affairs post-market surveillance, and vigilance reporting. Major Areas of Accountability Review complaints identified as potentially reportable to authorities and report or document a rationale for not reporting within the required time windows. Compose regulatory reports per FDA & EU Vigilance reporting timeframes and guidelines Support interactions with regulatory agencies. Provide support for the complaint reporting process during internal and external audits. Assist with assigned compliant reporting CAPA project activities, as needed. Support registration outside EU with appropriate documentation. Perform post-market surveillance and assist in risk management assessment. Coordinate and document recalls or other RA related field actions. Report and update appropriate regulatory bodies as needed. Maintain well-organized RA records that allow ready retrieval of required information. Maintain RA processes, procedures, and instructions to stay current with changing requirements. Assist with area documentation creation, SOP revisions, and review related to complaint reporting. Conform with and all local Compliance Standards Conform with Coloplast Q/EHS Policy Other duties as assigned Basic Qualifications BA/BS Degree or equivalent experience. 5+ years of experience in medical or scientific field in Quality, Regulatory, R&D or equivalent High level of familiarity with CE Marking, FDA and Canadian regulations, as well as applicable standards Ability to work flexible hours as needed for international communications Ability to interpret regulatory requirements into specific objectives and practical operational plans Ability to travel up to 10%, including international Working knowledge of up to date application for Post-market surveillance and risk management techniques Experience with FDA interactions/presentations preferred Experience with recalls, adverse event reporting, and post-market surveillance Competencies Quality mind-set, Right the First Time Focus. Able to work well in cross-functional teams, independent yet a team player. Mentor junior staff and serve as point of contact for this function Demonstrates a continuous desire to understand, learn, and implement up-to-date regulatory requirements, best practices, and trends. Analytical and able to work with complex data while still seeing the big picture. Excellent oral and written communication skills with the ability to listen, articulate, facilitate, and advocate. Maintains an extremely high attention to detail and follow through. Effective organizational skills. Demonstrates both creative and critical thinking skills. Proficiency in Microsoft Office including Outlook, PowerPoint, Word, and Excel. Pro-active; high-performance and results orientation Ability to consistently work, manage, and lead with ethical integrity. Open-minded with a global mindset. Embraces cultural differences within a global organization. Agile and adaptable to change. Personifies Coloplast Mission, Values, and Vision, as well as Coloplast Leadership Principles. Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14,000 people and with products available in more than 143 countries, we are one of the worlds leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things. Visit us on. Follow us on. Like us on. Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applic ble laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies. Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification. 56310 #LI-CO #LI-HYBRID Nearest Major Market: Minneapolis Find similar jobs: EOE M/W/Vets/Disabled