---
title: 'Quality & Regulatory Associate at Willow Innovations'
canonical: 'https://feeny.ai/job/quality-regulatory-associate-willow-innovations-remote-wb5m8jfztnxy'
type: 'job'
last_seen: '2026-09-17'
---

# Quality & Regulatory Associate at Willow Innovations

- **Company:** Willow Innovations
- **Location:** Remote
- **Work type:** remote
- **Posted:** 2026-09-16
- **Last confirmed live:** 2026-09-17
- **Apply:** https://job-boards.greenhouse.io/willowinnovations/jobs/6188829004

## Job description

Willow is a platform for products that help improve the lives and health of women. We are a mission-driven team of experienced inventors, mothers, and fathers dedicated to making a difference in women’s lives. The Willow™ Wearable Breast Pump, selected as one of TIME's 25 Best Inventions in 2017 and 2018 CES Innovation Award for Wearable Technologies, is the first solution in our platform.

## Role Overview

We are seeking a detail-oriented Part-Time Quality & Regulatory Associate to join our team. In this entry-level role, you will provide core support to the Quality and Regulatory team to help ensure our products maintain the highest standards of safety, compliance, and reliability.

You will gain hands-on experience across both Quality Assurance and Regulatory Affairs, taking ownership of product complaint investigations, material compliance reviews, and international regulatory documentation. This position is ideal for an ambitious candidate looking to launch a career in quality engineering, medical devices, or regulatory compliance within a fast-paced, mission-driven environment.

## Key Responsibilities

Complaint Investigation & Post-Market Quality

- Log, review, and evaluate incoming product complaints in the electronic CRM systems (salesforce) and provide input into investigations .
- Perform hands-on or technical reviews and testing on returned products to determine root causes of failures.
- Author concise, accurate, and compliant investigation reports to close out complaint files in accordance with company SOPs and regulatory standards (e.g., FDA 21 CFR 820, ISO 13485).
- Support with post market data analysis and monthly trending.

Material Compliance & Data Review

- Review material compliance test reports (e.g., biocompatibility, chemical safety, REACH, RoHS, Prop 65) provided by suppliers and third-party testing laboratories.
- Verify technical documentation and certificates of analysis to ensure raw materials and finished goods meet internal specifications and global standards.
- Track compliance data and collaborate with engineering and supply chain teams to resolve missing or non-compliant records.

International Regulatory Support

- Draft and maintain Declarations of Conformity (DoCs) and technical files required for international market access and other regulatory documentation as required.
- Assist in organizing regulatory submission packages and maintaining global product registration records.
- Monitor regulatory updates to support compliance requirements in target international markets.

Quality System Maintenance

- Maintain clear and audit-ready records within the eQMS.
- Assist with document control, change order reviews, and CAPA (Corrective and Preventive Action) support activities.
- Participate in continuous improvement initiatives across quality and regulatory workflows.

## Qualifications

Required

- Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, Quality Management, Regulatory Affairs, or a related technical discipline.
- 0–2 years of experience in quality, regulatory, laboratory testing, or engineering (academic projects and relevant internships count).
- Strong technical writing skills and high attention to detail when creating and reviewing documentation.
- Solid analytical and problem-solving skills; ability to interpret test reports and basic engineering specifications.
- Proficiency with standard office software (Microsoft Word, Excel, Google Workspace) and an aptitude for learning specialized systems (eQMS, PLM).
- Excellent communication and time-management skills, with the ability to work independently in a remote or hybrid environment.

## Preferred

- Familiarity with medical device regulations or quality standards (FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR).
- Basic experience using electronic Quality Management Systems (e.g., Arena, MasterControl, Greenlight Guru).
- Prior hands-on experience in a hardware or medical device testing lab setting.

Work Environment

- Work Location: Flexible — available as fully Remote (US/UK-based) or Hybrid (combining remote work with time at our Mountain View, CA office).
- Hours: This is a part-time position of 15-20 hours/week.

Willow is proud to be an equal opportunity workplace. We are committed to equal employment opportunities regardless of gender, race, religion, sexual orientation, gender identity, age, marital status, disability, or Veteran status.

## About Willow Innovations

## Company Overview
- **One-liner**: Willow Innovations designs and manufactures wearable, app-connected breast pumps and maternal health solutions to give mothers freedom and mobility.
- **Entity Type**: Private
- **Headquarters**: Mountain View, California, USA
- **Founded**: 2014
- **Founders**: Not publicly available (the company was built by a team of women innovators)

## Core Business
- Primary industry/industries: FemTech (Female Technology), Maternal Health, Consumer Medical Devices
- Target customers: B2C (new mothers and breastfeeding parents), B2B (healthcare providers, hospitals)
- Mission statement: “Bring joy to motherhood” and “Build solutions to mom’s most meaningful problems.”

## Products & Services
- **Willow Wearable Breast Pump**: The first all-in-one, in-bra wearable breast pump (launched 2017). FDA approved, clinically tested, 100% leak-proof, and app-connected. Selected as one of TIME’s 25 Best Inventions.
- **Willow 3.0**: The latest generation pump, featuring smart technology for personalized pumping, improved fit, and higher milk output.
- **Willow Accessories & Breast Care**: A range of accessories and breast care products designed to support the full pumping journey.
- **Willow App**: Companion app with smart controls, milk volume tracking, and in-app resources including access to International Board Certified Lactation Consultants and Willow Mom Coaches.
- **Elvie x Willow Platform**: Following a 2025 partnership/merger with Elvie, the combined entity is building a broader maternal care platform offering solutions in feeding and postpartum wellness.

## Market Standing
- **Valuation**: Not publicly disclosed (private company)
- **Key Metric**: Total employee count of approximately 90 as of latest reports
- **Notable Investors/Partners**: Not publicly disclosed in available sources; the company is noted as the only leading pump brand founded and based in the U.S. with a team built of women.
- **Growth Signals**: 
  - 120+ patents and 5 trademarks held
  - Merged with Elvie in 2025 to form a combined maternal care platform, signaling significant scale and market consolidation
  - Expanding from hardware into a full platform (app, coaching, community)
  - Actively hiring for roles including Senior Quality Engineer, Sr. Global Demand Planning Manager, Amazon Marketplace Manager, and Senior Software Engineer

## Competitive Advantages
- **First-Mover & IP Moat**: Invented the first wearable breast pump in 2017, with a strong patent portfolio (120+ patents).
- **Brand Trust & Clinical Validation**: FDA approved, clinically tested, and US-based manufacturing. Selected as one of TIME’s 25 Best Inventions.
- **Leak-Proof Technology**: The only 100% leak-proof wearable pump on the market, a critical differentiator for user experience.
- **FemTech Leadership**: As a pioneer in female-first technology, the company has deep understanding of women’s health needs, now amplified by the Elvie partnership.
- **Community & Support**: Offers in-app lactation consultants and Mom Coaches, creating a sticky ecosystem beyond just the hardware.

## Strategic Focus
- **Platform Expansion**: Moving from a single product (wearable pump) to a comprehensive maternal care platform (Elvie x Willow) covering feeding and postpartum wellness.
- **Global Reach**: Scaling through the Elvie partnership to reach a broader international audience.
- **Technology & AI Integration**: Leveraging “world-class smart technology” and exploring AI (e.g., “Ema AI for women’s health”) to enhance the user experience.
- **Product Innovation**: Continuing to develop new solutions for real-life problems, including accessories and breast care, not just pumps.

## Why Work Here
- **Mission-Driven Culture**: Strong focus on supporting mothers and bringing joy to motherhood. The company states, “Because when you’re taking care of the baby, who takes care of you? We do.”
- **Flexibility & Work-Life Balance**: 
  - Hybrid workspace (combination of remote and on-site work)
  - Flexible work schedules with work-from-home opportunities
  - “No Meeting Wednesdays” for uninterrupted focus time
  - Generous and flexible time off
- **Parental Leave**: New parents receive 16 weeks paid parental leave, plus six 4-day weeks to smoothly transition back to work.
- **Health & Wellness**: Comprehensive benefits including medical, dental, vision, wellness programs, health & gender affirmation reimbursement, 401k, life insurance, and disability options.
- **Diversity & Inclusion**: Strong commitment to building a diverse and inclusive workforce, with a stated mission to support all mothers on their unique motherhood journey.
- **Engineering & Innovation**: Opportunity to work on award-winning, patented technology that has a direct impact on users’ lives. Roles available in software engineering, quality engineering, and commercial operations.
- **Office Locations**: HQ in Mountain View, CA with remote/hybrid options available for some roles.

## Sources
1. [onewillow.com - About Page](https://onewillow.com/pages/about)
2. [onewillow.com - Homepage](https://onewillow.com/)
3. [onewillow.com - Careers Page](https://onewillow.com/pages/careers-legacy)
4. [Built In - Willow Innovations Profile](http://www.builtin.com/company/willow-innovations-inc)
5. [Greenhouse - Willow Innovations Job Board](http://job-boards.greenhouse.io/willowinnovations)

## Other roles at Willow Innovations

- [Program Manager, NPI](https://feeny.ai/job/program-manager-npi-willow-innovations-united-states-30wdf7dxb13p) — United States
- [Project Manager, Consumer Products – Maternal Care](https://feeny.ai/job/project-manager-consumer-products-maternal-care-willow-innovations-remote-dvhvyfh7sjyy)
- [Sr Director of Engineering (EE, Firmware, Software & Cloud)](https://feeny.ai/job/sr-director-of-engineering-ee-firmware-software-cloud-willow-innovations-9nvvcjmmny42) — Mountain View, CA
- [Senior Quality Engineer](https://feeny.ai/job/senior-quality-engineer-willow-innovations-mountain-view-w5g71rwxar70) — Mountain View, CA
- [Sr. Global Demand Planning Manager](https://feeny.ai/job/sr-global-demand-planning-manager-willow-innovations-united-states-vvw13ayp326p) — United States