Quality & Regulatory Associate

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 (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.

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.

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.

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 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.