---
title: 'Principal Regulatory Specialist at Tactile Medical'
canonical: 'https://feeny.ai/job/principal-regulatory-specialist-tactile-medical-new-brighton-kkp942s4r9yf'
type: 'job'
last_seen: '2026-09-15'
---

# Principal Regulatory Specialist at Tactile Medical

- **Company:** Tactile Medical
- **Location:** New Brighton, MN
- **Compensation:** $94k–$131k
- **Posted:** 2026-09-11
- **Last confirmed live:** 2026-09-15
- **Apply:** https://job-boards.greenhouse.io/tactilemedical/jobs/4392288009

## Job description

At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses.

This role is accountable for ensuring regulatory compliance across the product lifecycle for the company’s current product portfolio while proactively enabling innovation, market expansion, and business growth. Acting as a trusted advisor to cross functional leaders, the Principal Specialist provides deep regulatory expertise, interprets evolving regulations, and influences development strategy.

This individual contributor role is accountable for ensuring regulatory compliance across the product lifecycle while proactively enabling innovation, market expansion, and business growth. Acting as a technical advisor to cross-functional partners, the Principal Specialist provides deep regulatory expertise, interprets evolving regulations, and influences development strategy.

Accountabilities & Responsibilities

- 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.
- Provide regulatory review and technical guidance for labeling, promotional materials, and advertising to support compliance with applicable regulations.
- Act as a strategic regulatory partner to R&D, Quality, Clinical, Manufacturing, Marketing, and Supply Chain teams.
- Mentor and coach regulatory team members and cross-functional partners, strengthening overall regulatory capability within the organization.
- Deliver training and education on regulatory requirements, trends, and best practices to promote an enterprise-wide compliance culture.
- Collaborate with external consultants, notified bodies, and legal counsel to resolve complex regulatory challenges.
- Ensure timely execution and completion of regulatory activities to support product launch timelines and business milestones.
- Maintain accurate, compliant regulatory documentation and systems.
- Uphold the highest ethical standards, confidentiality, and integrity in all regulatory interactions.
- Perform other duties as required to support the regulatory function and business objectives.

## Qualifications

Required

- 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.

## Preferred

- Regulatory affairs certification.
- Experience with electrical-mechanical devices (IEC 60601).
- Experience with software as a medical device and/or software in a medical device (IEC 62304).

Knowledge & Skills

- Excellent working knowledge of FDA Code of Federal Regulations (21CFR), ISO 13485, MDD/MDR regulations and relevant regulations, requirements and standards related to medical devices.
- Strong proficiency with Microsoft Office tools including Word, Excel, PowerPoint, Teams or other relevant software.
- Strong verbal, written and presentation skills with the ability to effectively communicate at multiple levels in the organization.
- Possess exceptional written and verbal communication skills in preparing multi-stakeholder documents and presentations (e.g., scientific, clinical/medical, regulatory reviewer).
- Strong knowledge in medical device Design Controls and Risk Management.
- Capable of managing multiple projects and complex timelines in a team environment.
- Cross functional collaboration skills needed to foster alignment.
- Excellent influence and impact skills.
- Strong analytical and critical thinking skills.
- Strong cross-functional skills to foster alignment.

Our total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insurance, disability coverage, and other life and work wellness benefits and discounts. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions.

Below is the starting salary or hourly range for this position, although offers may differ based on the candidate's location, job-specific knowledge, skills and experience.

US Pay Range $93,600—$131,040 USD

To learn more about our Privacy Statement follow this link - https://tactilemedical.com/privacy-statement/

To learn more about our California Privacy Notice follow this link - https://tactilemedical.com/california-privacy-notice/

## About Tactile Medical

## Company Overview
- **One-liner**: Tactile Medical develops at-home pneumatic compression devices to treat lymphedema and chronic venous insufficiency, helping patients manage chronic swelling at home.
- **Entity Type**: Public (ticker not listed in provided search results)
- **Headquarters**: Minneapolis, Minnesota, USA (corporate HQ); manufacturing in New Brighton, Minnesota
- **Founded**: Not publicly available
- **Founders**: Not publicly available

## Core Business
- **Primary industry**: Medical devices (lymphedema treatment, chronic venous insufficiency, airway clearance)
- **Target customers**: B2B (clinicians, hospitals, clinics) and B2C (patients)
- **Mission**: “We reveal and treat people with underserved chronic conditions and help them care for themselves at home” [tactilemedical.com/about-us/](https://tactilemedical.com/about-us/)

## Products & Services
- **Flexitouch® Plus system**: Advanced pneumatic compression device for treating lymphedema and chronic venous insufficiency. Clinically proven to reduce swelling and discomfort throughout the body. [tactilemedical.com/](https://tactilemedical.com/)
- **Nimbl™**: Small, light, compact pneumatic compression controller designed for portability and improved patient experience. [tactilemedical.com/](https://tactilemedical.com/)
- **AffloVest**: Airway clearance therapy device for chronic respiratory conditions and neuromuscular disorders, helping loosen and move mucus for easier breathing. [tactilemedical.com/](https://tactilemedical.com/)

## Market Standing
- **Valuation/Market Cap**: Not publicly available from search results
- **Key Metric**: Not publicly available (no revenue or funding data in search results)
- **Notable Investors/Partners**: Not publicly available from search results
- **Growth Signals**: Nationwide team of Territory Account Managers and Patient Education Consultants; tens of thousands of patients treated annually; expansion into airway clearance with AffloVest; US-based manufacturing. [tactilemedical.com/about-us/](https://tactilemedical.com/about-us/)

## Competitive Advantages
- **Patient-first approach**: Comprehensive support including personalized setup, training, follow-up, and reimbursement navigation. [tactilemedical.com/about-us/](https://tactilemedical.com/about-us/)
- **Clinically proven devices**: Backed by clinical research and used by tens of thousands of patients annually.
- **US domestic manufacturing**: Engineering, Quality, R&D, and Supply Chain teams in New Brighton, MN, ensuring quality control and innovation. [tactilemedical.com/about-us/careers/](https://tactilemedical.com/about-us/careers/)
- **Integrated care model**: Combination of innovative devices, personalized care, and support services increases clinical efficacy and reduces healthcare costs.

## Strategic Focus
- **Current priorities**: Expanding patient access to lymphedema and chronic venous insufficiency treatments; developing next-generation devices (e.g., Nimbl); entering new therapeutic areas (airway clearance with AffloVest); strengthening field sales and patient education network.
- **Direction for growth**: Continued innovation in at-home therapy devices, broadening reimbursement coverage, and scaling the national field team to reach more underserved patients.

## Why Work Here
- **Culture highlights**: Values include transparency, drive, collaboration, embracing change, and compassion. Emphasis on patient-first mindset and making a meaningful difference. [tactilemedical.com/about-us/](https://tactilemedical.com/about-us/)
- **Work setting**: Hybrid (corporate HQ and manufacturing), remote, field-based, and office roles available. Field roles include Territory Account Managers and Patient Education Consultants. [tactilemedical.com/about-us/careers/](https://tactilemedical.com/about-us/careers/)
- **Notable perks**: Opportunity to work with a mission-driven team focused on improving quality of life for patients with chronic conditions; comprehensive support from reimbursement experts and clinical staff; US-based manufacturing and R&D.

## Sources
1. [tactilemedical.com/about-us/](https://tactilemedical.com/about-us/)
2. [tactilemedical.com/about-us/careers/](https://tactilemedical.com/about-us/careers/)
3. [tactilemedical.com/](https://tactilemedical.com/)
4. [tactilemedical.com/about-us/leadership/](https://tactilemedical.com/about-us/leadership/)
5. [tactilemedical.com/about-us/careers/our-purpose/](https://tactilemedical.com/about-us/careers/our-purpose/)
6. [job-boards.greenhouse.io/tactilemedical](https://job-boards.greenhouse.io/tactilemedical)

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