Medical Device QA & Regulatory Associate (Part-Time, Remote)

Willow Innovations; United States; In loco; USD 25.000 - 39.000; Part-time

Descrizione del lavoro

Willow is seeking a detail-oriented, part-time Quality & Regulatory Associate to support the Quality and Regulatory teams. This entry-level role covers complaint investigations, material compliance reviews, and international regulatory documentation, with remote or hybrid work options.

You will gain hands-on experience in QA and regulatory affairs for medical devices in a fast-paced, mission-driven environment, contributing to product safety and compliance across global markets.

Competenze

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, Quality Management, Regulatory Affairs, or related field.
• 0–2 years of experience in quality, regulatory, laboratory testing, or engineering.
• Strong technical writing and high attention to detail.
• Proficiency with Microsoft Word, Excel, Google Workspace and aptitude for learning eQMS/PLM.
• Excellent communication and time-management; able to work independently in remote or hybrid.
• Preferred: familiarity with medical device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR).

Mansioni

• Log, review, and evaluate incoming product complaints in CRM and assist investigations.
• Perform hands-on or technical reviews and testing on returned products to identify root causes.
• Draft concise, compliant investigation reports per SOPs and regulatory standards.
• Support post-market data analysis and monthly trending.
• Review material compliance test reports and verify certificates of analysis.
• Track compliance data with engineering and supply chain to resolve gaps.
• Draft and maintain Declarations of Conformity and technical files for international market access.
• Assist regulatory submission packages and maintain global product registration records.
• Monitor regulatory updates to support compliance in international markets.
• Maintain audit-ready records in the eQMS; document control and CAPA support.
• Participate in continuous improvement initiatives.

Conoscenze

Technical writing

Analytical skills

Communication

Time management

Formazione

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

Strumenti

eQMS

PLM

Arena

MasterControl

Greenlight Guru

Descrizione del lavoro

Willow is seeking a detail-oriented, part-time Quality & Regulatory Associate to support the Quality and Regulatory teams. This entry-level role covers complaint investigations, material compliance reviews, and international regulatory documentation, with remote or hybrid work options.

You will gain hands-on experience in QA and regulatory affairs for medical devices in a fast-paced, mission-driven environment, contributing to product safety and compliance across global markets.