Willow Innovations
Quality & Regulatory Associate
About this role
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-TimeQuality & 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.