Quality & Regulatory Associate

Quality & Regulatory Associate

This part-time, entry-level role supports the quality and regulatory functions behind innovative products designed to improve women's health and well-being. You'll gain hands-on experience across complaint investigations, material compliance, regulatory documentation, and quality system activities. The role combines analytical work, technical documentation, and collaboration with engineering, supply chain, and other cross-functional teams. You'll help investigate product issues, identify root causes, and maintain accurate records that support product safety and reliability.

You'll also contribute to international regulatory activities and ensure technical documentation remains complete, accurate, and audit-ready. This is an opportunity to build practical experience in medical devices, quality engineering, and regulatory compliance within a fast-paced environment. The position offers flexible remote work in the US, with a part-time schedule of 15–20 hours per week.

Accountabilities:

• Log, review, and evaluate incoming product complaints in electronic CRM systems, including Salesforce, and provide input into investigations.
• Conduct hands-on and technical reviews or testing of returned products to help identify failure modes and root causes.
• Prepare clear, accurate, and compliant complaint investigation reports in accordance with applicable procedures and quality standards.
• Support post-market data analysis and monthly trend reporting to identify recurring issues and emerging product concerns.
• Review supplier and third-party material compliance documentation, including biocompatibility, chemical safety, REACH, RoHS, and Proposition 65 reports.
• Verify technical documentation and certificates of analysis to confirm that raw materials and finished products meet applicable specifications and global requirements.
• Track compliance information and collaborate with engineering and supply chain teams to resolve missing, incomplete, or non-compliant records.
• Draft and maintain Declarations of Conformity, technical files, and other regulatory documentation supporting international market access.
• Assist with regulatory submission packages and maintain accurate global product registration records.
• Monitor relevant regulatory developments and help assess their impact on products and compliance activities.
• Maintain organized, accurate, and audit-ready records within the electronic Quality Management System (eQMS).
• Support document control, change order reviews, CAPA activities, and continuous improvement initiatives across quality and regulatory workflows.

Requirements:

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, Quality Management, Regulatory Affairs, or another relevant technical discipline.
• 0–2 years of experience in quality, regulatory affairs, laboratory testing, engineering, or a related field; relevant academic projects and internships are considered.
• Strong technical writing skills and exceptional attention to detail when preparing and reviewing documentation.
• Solid analytical and problem-solving abilities, with the capacity to interpret test reports and basic engineering specifications.
• Proficiency with Microsoft Word, Excel, Google Workspace, and other standard productivity tools.
• Ability and willingness to learn specialized systems such as eQMS and Product Lifecycle Management (PLM) platforms.
• Strong communication and time-management skills, with the ability to organize work independently in a remote or hybrid environment.
• Familiarity with medical device regulations and quality standards such as FDA 21 CFR 820, ISO 13485, ISO 14971, or EU MDR is preferred.
• Basic experience with electronic Quality Management Systems such as Arena, Master…