Quality & Regulatory Associate

Location: Remote

Department: Clinical Regulatory Quality (CRQ)

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.