Regulatory Affairs & Quality Associate
Location: Huntington Beach, CA
Compensation: $80,000 - $95,000k (Depending on experience)
About the Role
At SprintRay, we are in a super-charged growth mode, constantly innovating while maintaining thehighest quality standards for our products and processes. Our mission is to deliver safe, reliable, and innovative medical devices that improve patient outcomes. We are seeking a highly motivated candidate to support our medical device portfolio. This role is critical in ensuring compliance with global regulatory and quality requirements and providing guidance on applicable standards. The ideal candidate will be proactive, detail-oriented, and experienced in navigating the regulatory landscape for medical devices. This role requires strong analytical skills, attention to detail, and a collaborative approach to regulatory compliance.
Key Responsibilities
Prepare, review, and maintain Post-Market Surveillance (PMS) Reports in accordance with applicable regulatory requirements.
Prepare and maintain Usability Engineering / Human Factors Reports and related documentation.
Prepare, review, and maintain Clinical Evaluation Reports (CERs).
Prepare Post-Market Clinical Follow-Up (PMCF) Reports and supporting documentation.
Prepare Periodic Safety Update Reports (PSURs), as applicable.
Support the medical device complaint handling process, including:
Review and documentation of customer complaints.
Evaluation of complaints for reportability and regulatory impact.
Coordination of complaint investigations with Quality, Engineering, Manufacturing, and other relevant departments.
Preparation and maintenance of complaint investigation reports.
Identification and documentation of root cause, investigation findings, and corrective actions, as applicable.
Support complaint trending and trend reporting to identify potential product quality, safety, or performance signals.
Support vigilance reporting and regulatory reporting when required.
Review controlled documents from cross-functional departments for regulatory compliance, accuracy, completeness, and consistency, including:
Design Control documentation
Process Validation documentation
Risk management documentation
Manufacturing and quality documentation
Regulatory and product documentation
Support document control activities, including:
Assignment and maintenance of controlled document numbers and naming conventions.
Document routing and approval workflows.
Document Change Orders (DCOs) and document change control.
Revision tracking and implementation.
Maintenance and archival of obsolete documents.
Ensuring appropriate approvals and effective dates are documented.
Maintain accurate and up-to-date controlled document records in accordance with the company's Quality Management System (QMS).
Review and approve product labeling, including labels, Instructions for Use (IFUs), packaging, and applicable product information, for regulatory and quality compliance.
Review and approve Safety Data Sheets (SDSs) and ensure consistency with applicable regulatory and product requirements.
Support product change assessments, including evaluation of regulatory and quality impacts associated with product, process, material, labeling, manufacturing, and supplier changes.
Support preparation and maintenance of EUDAMED registrations and related EU regulatory information.
Support EU REACH compliance and product registrations, including collection, review, and maintenance of required product and material information.
Maintain regulatory and product registration records and support regulatory submission and registration activities as needed.
Assist with preparation for and follow-up on internal, external, regulatory, and Notified Body audits.
Support responses to audit findings, regulatory inquiries, and documentation requests.
Collaborate with Quality, Regulatory, R&D, Engineering, Manufacturing, Clinical, and other cross-functional teams to ensure regulatory and QMS…