Bachelor's degree in engineering, Life Sciences, Regulatory Affairs, Biomedical Sciences, or a related field.
0-3 years of experience in Regulatory Affairs or Quality Assurance within the medical device industry preferred.
Familiarity with ISO 13485 and FDA Quality System requirements; experience with medical device regulations preferred.
Basic understanding of EU MDR and post-market surveillance requirements preferred.
Strong attention to detail and organizational skills.
Ability to manage multiple priorities in a fast-paced environment.
Strong written and verbal communication skills.
Responsibilities
Prepare and maintain Post-Market Surveillance (PMS) Reports according to regulatory requirements.
Prepare and maintain Usability Engineering / Human Factors Reports and documentation.
Review and maintain Clinical Evaluation Reports (CERs).
Support the medical device complaint handling process, including documentation and investigation coordination.
Review controlled documents for regulatory compliance and accuracy across various departments.
Support document control activities, including routing, approval workflows, and revision tracking.
Collaborate with cross-functional teams to ensure compliance with regulatory and quality management system requirements.
Benefits
Full-time employment opportunity.
Collaborative work environment with cross-functional teams.
Opportunity to work in a fast-paced and dynamic industry.
Exposure to global regulatory standards and practices.
Full Job Description
Regulatory Affairs & Quality Associate
Location: Huntington Beach, CA Compensation: $80,000 - $95,000k (Depending on experience)
About the Role
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 requirements are met.
Monitor applicable regulatory requirements and support implementation of new or revised regulations, standards, and guidance.
Maintain confidentiality and ensure the integrity, accuracy, and traceability of regulatory and quality records.
Required Qualifications
Bachelor's degree in engineering, Life Sciences, Regulatory Affairs, Biomedical Sciences, or a related technical/scientific field.
0-3 years of experience in Regulatory Affairs, Quality Assurance, or a related function within the medical device industry is preferred.
Familiarity with ISO 13485 and FDA Quality System requirements; experience with medical device regulations is preferred.
Basic understanding of EU MDR and post-market surveillance requirements is preferred.
Strong attention to detail, accuracy, and organizational skills.
Ability to manage multiple priorities and deadlines in a fast-paced environment.
Strong written and verbal communication skills.
Strong technical writing and documentation skills.
Ability to review technical and regulatory documentation for accuracy, completeness, consistency, and compliance.
Proficiency in Microsoft Office Suite, particularly Word, Excel, and PowerPoint.
Ability to work independently while also collaborating effectively within a cross-functional team.
Demonstrated ability to maintain confidentiality, document integrity, and accurate records.
Strong analytical and problem-solving skills, with the ability to identify discrepancies and follow issues through resolution.
Willingness and ability to learn and apply new regulatory requirements, standards, and internal procedures.
