Hiring: Principal Regulatory Specialist Company: Tactile Medical Location: New Brighton, MN Job Posted Time: 2026-09-12 11:24:53 Target Skills & Keywords : Microsoft Excel, Microsoft Office, Microsoft PowerPoint, R, Regulatory Compliance, Risk Management About the job Experience: •7 years of medical device regulatory affairs experience, including at least 2 years hands-on experience with FDA submissions (510(k), PMA, IDE) for Class II and/or Class III devices. •At least 2 years hands-on experience with FDA submissions (510(k), PMA, IDE) for Class II and/or Class III devices. Required Skills: •Develop and execute regulatory strategies for new and existing products, aligning regulatory pathways with business objectives. •Influence product development, portfolio planning, and lifecycle management decisions by identifying regulatory risks, opportunities, and early tradeoffs. •Lead the preparation and technical review of regulatory submissions, including 510(k)s, q-submissions, and other global filings, as appropriate. •Determine submission requirements and provide recommendations to ensure alignment across Engineering, Clinical, Quality, and Manufacturing. •Ensure accurate, timely maintenance of UDI/GUDID data, licenses, registrations, listings, and post approval commitments. •Lead the development, interpretation, and continuous improvement of regulatory policies, procedures, and SOPs, in alignment with Regulatory management and applicable document-control processes. •Monitor, assess, and communicate regulatory changes, translating requirements into actionable guidance for stakeholders. •Partner with Quality and Operations to support audits, inspections, recalls, and remediation activities, ensuring effective regulatory risk management. Qualifications: •Bachelor’s degree or equivalent combination of education and experience. •Minimum of 7 years of medical device regulatory affairs experience, including at least 2 years hands-on experience with FDA submissions (510(k), PMA, IDE) for Class II and/or Class III devices. •Demonstrated experience developing regulatory strategies and leading execution of complex submissions and product lifecycle activities. Compensation: •$93,600 - $131,040 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!