Tactile Medical · 13 hours ago
Director Regulatory and Quality Systems
Minneapolis, Minnesota
Full-time
Onsite
Director/Executive
$133K/yr - $199K/yr
10+ years expTactile Medical specializes in developing at-home therapy devices for various medical conditions. The Director of Regulatory & Quality Systems will lead the regulatory strategy and ensure the effectiveness of the Quality Management System in compliance with applicable regulatory requirements for Class II medical devices.
Health CareMedicalMedical Device
Responsibilities
Develop and execute regulatory strategies to support new product introductions, modifications, and ongoing compliance for Class II medical devices
Lead preparation, submission, and maintenance of regulatory filings including 510(k)s, technical files, annual reports, and global registrations
Serve as primary liaison with FDA and other regulatory authorities; manage communications, inspections, and responses
Monitor evolving regulatory requirements and proactively assess impact on the business
Provide regulatory guidance to R&D, Clinical, Marketing, and Operations teams throughout the product lifecycle
Oversee the company’s Quality Management System (QMS) to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable standards
Lead internal and external audits, including FDA inspections and notified body audits; ensure timely and effective CAPA management
Drive continuous improvement initiatives across quality processes, documentation, and system performance
Oversee Post Market Surveillance to ensure robust processes for complaint handling, nonconformance management, supplier quality, and risk management
Partner with Operations and Engineering to ensure quality is embedded throughout manufacturing and product development
Lead and develop a high performing Regulatory & Quality team, fostering accountability, technical expertise, and professional growth
Collaborate with executive leadership to align regulatory and quality strategies with business objectives
Provide regular updates to senior leadership on compliance status, regulatory risks, and quality metrics
Represent the company in regulatory and quality matters with external partners, auditors, and stakeholders
Other duties as assigned
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or related field
10+ years of experience in Regulatory Affairs and/or Quality within the medical device industry
Proven leadership experience managing regulatory and quality functions for Class II medical devices
Strong working knowledge of FDA regulations (21 CFR Part 820), ISO 13485, ISO 14971, and related standards
Demonstrated success preparing and submitting 510(k)s and interacting with FDA
Experience leading audits, inspections, and cross‑functional compliance initiatives
Strong expertise in FDA regulations (21 CFR Part 820, Part 11) and ISO standards (ISO 13485, ISO 14971)
Proven experience with Class II medical devices, including 510(k) submissions and design controls
Deep understanding of Quality Management Systems and continuous improvement practices
Ability to lead regulatory strategy and interpret requirements for cross‑functional teams
Skilled in managing FDA inspections, notified body audits, and regulatory communications
Strong analytical skills with the ability to assess data, identify trends, and drive CAPA actions
Proficient in risk management tools such as hazard analysis and FMEA
Solid understanding of product development from concept through commercialization
Excellent communication and executive‑level presentation skills
Demonstrated leadership ability to build and develop high‑performing teams
Strong judgment, integrity, and decision‑making in regulated environments
Effective project management skills with the ability to prioritize and deliver in fast‑paced settings
Preferred
Advanced degree (MS, MBA, RAC, or equivalent)
Experience in a publicly traded company, including familiarity with SOX and corporate governance expectations
Background supporting global regulatory submissions (EU, Canada, APAC)
Experience with combination products or digital health components (if applicable)
Company
Tactile Medical
Tactile Medical develops medical devices that support the treatment of edema and vascular diseases at home.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$55.7MKey Investors
Radius VenturesGalen Partners
2023-02-23Post Ipo Equity· $32.5M
2016-07-28IPO
2012-10-05Series B· $10.4M
Leadership Team
Dan Reuvers
Chief Executive Officer
Brent Moen
Chief Financial Officer
Recent News
2026-01-05
Tactile Systems Technology, Inc.
2025-11-04
2025-11-04
Company data provided by crunchbase