Remote Part-Time Quality & Regulatory Specialist

Femtech Insider Ltd.; United States; On-site; 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 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