Quality & Regulatory Associate

Femtech Insider Ltd.; United States; Hybrid; USD 25,000 - 44,000; Part time

Benefits offered by this job

Remote work option

Hybrid work option

Job summary

Willow is seeking a detail-oriented part-time Quality & Regulatory Associate to support the Quality and Regulatory team, focusing on complaint investigations, material compliance, and international regulatory documentation. This entry-level position aims to launch a career in quality engineering and regulatory matters within a fast-paced, mission-driven environment.

Responsibilities include investigation reporting, material compliance reviews, and maintaining regulatory files under FDA 21 CFR

Qualifications

• 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.

Responsibilities

• Log, review, and evaluate incoming product complaints in the electronic CRM systems 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.
• 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.
• Draft and maintain Declarations of Conformity 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.
• Maintain clear and audit-ready records within the eQMS.
• Assist with document control, change order reviews, and CAPA support activities.
• Participate in continuous improvement initiatives across quality and regulatory workflows.

Skills

Biomedical Engineering

Regulatory writing

Analytical thinking

Documentation

Remote/hybrid work

Education

Bachelor’s degree in Biomedical Engineering, Life Sciences, or related

Tools

eQMS

PLM

Microsoft Word/Excel

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.