Regulatory Affairs Specialist II

Company DescriptionMedical Device IndustryJob DescriptionJob Title: Regulatory Affairs Specialist IIJob Location: Chaska 1000 Lake Hazeltine Drive Chaska MN 55318 United States Job Description/Comment: Responsibilities: The Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programs for adverse event, vigilance and recall reporting.Ensures timely preparation of organized and scientifically valid reports both internally and externallyCoordinates and manages the post-market regulatory reporting and compliance activities in accordance with Company procedures and regulatory requirements.Creates, monitors and controls Regulatory project schedules related to postmarket activitiesKey accountability is to maintain global regulatory compliance programs for product corrective action, adverse event reporting and vigilance requirements.Coordination of on-going regulatory activities with Corporate Quality and Regulatory Affairs and coordinating and communicating with domestic and international business partners and direct interaction with regulatory agencies on post-market product issues and questionsImplements, facilitates, and reports on CLIENT regulatory programs.Implements regulatory activities such as obtaining global regulatory clearances and/or approvals, preparing device listings, performing import/export requirements, fulfilling regulatory compliance obligations, and maintaining regulatory intelligence.Prepares and maintains regulatory licenses, reports, and listings.Minimum qualifications: Bachelor's degree in sciences, engineering, or technical field and 9 years of relevant experience or a Master's degree and 7 years of relevant experience or PhD and 4 years of relevant experience for STAFF level. Bachelor's degree in sciences, engineering, or technical field and 5 years of relevant experience or a Master's degree and 2 years of relevant experience or PhD and 1 year of relevant experience for SENIOR level.Professionals with technical skills stated below but less relevant experience may be considered for ASSOCIATE level Regulatory Affairs.Work experience with medical devices, pharmaceuticals and/or in-vitro diagnostic fields.Previous regulatory experience desirable.Ability to prioritize assigned work.Ability to learn regulatory procedures.Ability to communicate accurately with internal and external contacts.Ability to work with team members to resolve problems and achieve goals.Experience with LEAN principles desirable.Experience with risk management (FMEA/HHA) desirable.RAC desired. Shift (Hours by Location):MN - CHASKA 8:00am - 5:00pm Additional Job Details: The Staff Regulatory Affairs Specialist position requires a high-level strategist, individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for pre- and post-market activities and managing complex issues that may have significant impact on the business. This individual contributor will manage global regulatory initiatives.QualificationsMinimum qualifications: Bachelor's degree in sciences, engineering, or technical field and 9 years of relevant experience or a Master's degree and 7 years of relevant experience or PhD and 4 years of relevant experience for STAFF level. Bachelor's degree in sciences, engineering, or technical field and 5 years of relevant experience or a Master's degree and 2 years of relevant experience or PhD and 1 year of relevant experience for SENIOR level.Professionals with technical skills stated below but less relevant experience may be considered for ASSOCIATE level Regulatory Affairs.Work experience with medical devices, pharmaceuticals and/or in-vitro diagnostic fields.Previous regulatory experience desirable.Ability to prioritize assigned work.Ability to learn regulatory procedures.Ability to communicate accurately with internal and external contacts.Ability to work with team members to resolve problems and achieve goals.Experience with LEAN principles desirable.Experience with risk management (FMEA/HHA) desirable.RAC desired.Additional Information Additional Job Details: The Staff Regulatory Affairs Specialist position requires a high-level strategist, individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for pre- and post-market activities and managing complex issues that may have significant impact on the business. This individual contributor will manage global regulatory initiativesJob Location