Regulatory Affairs Specialist

Regulatory Affairs SpecialistLocation: Minneapolis, MN, USThe Regulatory Affairs Specialist is responsible for day-to-day regulatory affairs tasks required to maintain compliance with Coloplast's quality system and applicable regulatory requirements. This position will also prepare, monitor, and communicate status of regulatory submissions and perform duties related to regulatory affairs post-market surveillance, change analysis, claims review, and vigilance reporting. This position is also responsible for design control compliance for assigned products and will support development and execution of regulatory strategies per timelines to ensure clearance / approval in the assigned geographies.Major Areas of Accountability:Support compilation of high-quality regulatory submissions for all products to expedite clearance/approval and sustain commercial availability for all productsSupport interactions with regulatory agenciesSupport compilation of technical documentation to support CE-marking for assigned productsSupport registration outside EU with appropriate documentation and maintain regulatory registrations and licensesReview and approve change controls, supplier evaluations, and non-conforming material reports for potential impact on regulatory statusPrepare submissions, supplements, amendments, and letters to file as needed to document rationaleKeep design history file (DHF) currentReview and approve IFU, labels and promotion materialWork with Clinical and Quality to prepare post-market data for inclusion in periodic reports required by regulation and other post-market surveillance activities as neededParticipate in CAPA investigations, root cause analyses, corrective actions, and verification of effectivenessCoordinate and document recalls or other RA related field actionsReport and update appropriate regulatory bodies as neededParticipate in notified body, FDA, and internal audits, including audit responsesReview complaints identified as potentially reportable to authorities and report or document a rationale for not reporting within the required time windowsAnalyze, summarize, prepare, and present data for Management Review meetingsMaintain RA processes, procedures, and instructions to stay current with changing requirementsConform with Coloplast Code of Conduct and all local Compliance StandardsConform with Coloplast Q/EHS PolicyOther duties as assigned.Coordinator Role(s): Specified on LOG 100250. Signature Authority: Specified on LOG 100250Basic Qualifications:BA/BS Degree or equivalent experience, scientific field degrees preferred3+ years' experience in regulatory affairs in Medical Device industryFamiliarity with FDA and EU regulations for medical devicesPrefer candidates with CE marking and Health Canada experienceExperience with FDA interactions/presentations preferredExperience with recalls, adverse event reporting, biocompatibility, claims review, and post-market surveillance desirableKnowledge, Skills, and Abilities:Quality mindset-Right the First Time FocusAble to work well in cross-functional teams, independent yet a team playerDemonstrates a continuous desire to understand, learn and implement up-to-date regulatory requirements, best practices and trendsAnalytical and able to work with complex data while still seeing the big pictureExcellent oral and written communication skills with the ability to listen, articulate, facilitate, and advocateMaintains an extremely high attention to detail and follow throughEffective Organizational skillsDemonstrates both creative and critical thinking skillsProficiency in Microsoft Office including Outlook, PowerPoint, Word, and ExcelPro-active; high-performance and results orientationAbility to consistently work, manage, and lead with ethical integrityOpen-minded with a global mindsetEmbraces cultural differences within a global organizationAgile and adaptable to changePersonifies Coloplast Mission, Values, and Vision as well as Coloplast Leadership PrincipalsAt Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Coloplast