Senior Regulatory Affairs Specialist

CANDIDATES CURRNETLY WORKING UNDER F1 OPT/F1 OPT STEM/H1-B WILL NOT BE CONSIDERED. W2 CANDIDATES ONLYSr. Regulatory Affairs Specialist (12 month contract // Boulder, CO or Minneapolis, MN):Candidate is required to work on site in Boulder, CO or Minneapolis, MN at least 3 days per weekHM's Top Needs:Experience with US and EU change assessmentsExperience reviewing and support MDR Clinical Evaluation documentation as a Regulatory stakeholder (not necessarily as an author)Willingness to be adaptive, collaborative, and supportive of the Regulatory teamDuties:Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.Leads or compiles all materials required in submissions, license renewal and annual registrations.Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.Monitors and improves tracking / control systems.Keeps abreast of regulatory procedures and changes.May direct interaction with regulatory agencies on defined matters.Recommends strategies for earliest possible approvals of clinical trials applications.Must Have:4+ years' experience in regulatory (medical devices)Strong experience with change assessments for EU/US marketed productsStrong organizational skills to manage multiple projects simultaneously under limited supervisionAnalytical thinking to identify potential regulatory issues and develop effective solutions.Demonstrated excellent organizational skillsDemonstrated technical writing skillsExcellent attention to detailExcellent communication skillsExperience as regulatory lead in core teams for sustaining and development projectsExpert proficiency in Microsoft Office suite, including Word and ExcelProficient at managing multiple projects at onceRegulatory assessment of change orders emphasis on US and EUFamiliar with ISO 13485, FDA Medical Devices Part 820, and Medical Device Good Documentation PracticesNice to Have510(k) authorshipAdobe software skillsRAPS Regulatory Affairs Certification (RAC)

Created: 2025-01-30