Remote Quality & Regulatory Associate – Medical Devices

Willow Innovations, Inc.; United States; On-site; USD 25,000 - 39,000; Part time

Job summary

Willow Innovations, Inc. seeks a detail-oriented Part-Time Quality & Regulatory Associate to support our Quality and Regulatory team, ensuring safety, compliance, and reliability for our medical device products.

In this entry-level role, you will handle complaint investigations, material compliance reviews, and international regulatory documentation, gaining hands-on experience across QA and regulatory affairs in a fast-paced, mission-driven environment.

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 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

• Complaint Investigation & Post-Market Quality: Log, review, and evaluate incoming product complaints in CRM systems and provide input into investigations; perform hands-on or technical reviews and testing on returned products to determine root causes; author concise, accurate investigation reports to close out complaint files per SOPs and regulatory standards; support with post market data analysis and monthly trending.
• Material Compliance & Data Review: Review material compliance test reports (biocompatibility, chemical safety, REACH, RoHS, Prop 65); 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; 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 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

Technical writing

Attention to detail

Analytical thinking

Communication

Time management

Remote/hybrid work

Office software

Education

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, Quality Management, Regulatory Affairs, or related

Tools

eQMS

PLM

Arena

MasterControl

Greenlight Guru

Job description

Willow Innovations, Inc. seeks a detail-oriented Part-Time Quality & Regulatory Associate to support our Quality and Regulatory team, ensuring safety, compliance, and reliability for our medical device products.

In this entry-level role, you will handle complaint investigations, material compliance reviews, and international regulatory documentation, gaining hands-on experience across QA and regulatory affairs in a fast-paced, mission-driven environment.