Regulatory Affairs & Quality Systems Assistant

Regulatory Affairs & Quality Systems Assistant Grass Valley, CA 95945 $58,654.46 - $70,637.63 a year - Full-time $58,654.46 - $70,637.63 a year - Full-time We are seeking a detail-oriented and proactive Regulatory Affairs & Quality Systems Assistant to support our Quality Management System (QMS), regulatory compliance activities, and general business operations. This position plays an important role in maintaining compliance with medical device regulations and quality standards while providing administrative and operational support to the broader team. The ideal candidate is highly organized, capable of managing multiple priorities, and interested in developing expertise in medical device quality and regulatory affairs. Key ResponsibilitiesQuality System Support Assist in maintaining the Quality Management System (QMS) in compliance with applicable regulations and standards, including

FDA 21 CFR

Part 820 and

ISO 13485.

Support document control activities, including creation, revision, approval routing, distribution, and archiving of quality documents. Maintain quality records and ensure proper document retention. Assist with internal audits and external audit preparation. Support training record management and employee training coordination. CAPA and Complaint Handling Assist with the administration and tracking of Corrective and Preventive Action (CAPA) activities. Support investigation activities by collecting and organizing data. Maintain CAPA logs and ensure timely follow-up of action items. Assist in complaint handling processes, including complaint documentation, record maintenance, and trend reporting. Support post-market surveillance and quality metrics reporting. Regulatory Affairs Support Assist with preparation and maintenance of regulatory submissions and registrations. Support product labeling reviews and document updates. Maintain regulatory files and product technical documentation. Assist with regulatory correspondence and recordkeeping. Support international regulatory compliance activities as required. Operational and Administrative Support Coordinate meetings, maintain project schedules, and track action items. Assist with supplier documentation and quality records. Support inventory, purchasing, and manufacturing documentation activities as needed. Help organize quality and regulatory projects across departments. Perform other administrative and operational duties to support company objectives. QualificationsRequired Associate degree or Bachelor's degree in a technical, scientific, engineering, business, or related field, or equivalent experience. Strong organizational and administrative skills. Excellent written and verbal communication skills. Proficiency with Microsoft Office (Word, Excel, Outlook, PowerPoint). Ability to manage multiple projects and deadlines. Strong attention to detail and documentation accuracy. Preferred Experience working in a regulated industry, preferably medical devices. Familiarity with FDA regulations, ISO 13485, and quality systems. Experience with CAPA, complaint handling, document control, or auditing activities. Experience with quality management systems (QMS). Personal Attributes Self-motivated and dependable. Strong problem-solving skills. Ability to work independently and as part of a team. Willingness to learn and grow within quality and regulatory functions. Professional and customer-focused attitude.

Pay:

$58,654.46 - $70,637.63 per year

Benefits:

401(k) Dental insurance Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person