Regulatory Affairs & Quality Assurance Manager

Hycor•Garden Grove, CA

5d•Onsite

About The Position

The Regulatory Affairs & Quality Assurance Manager oversees regulatory affairs and quality assurance activities to ensure compliance with U.S. FDA, European Union, and other applicable international requirements. The role combines strategic guidance with hands-on involvement in regulatory submissions, quality management systems, and risk management for medical device or in vitro diagnostic (IVD) products. The manager develops regulatory strategies for pre-market and post-market activities; manages submissions, product documentation, and regulatory communications; and oversees the quality system, audits, corrective actions, risk management, complaints, and post-market activities. The position also provides guidance to executive management and cross-functional teams, supervises assigned personnel, and supports continuous improvement and a strong culture of quality and compliance. The role is on-site in Garden Grove, California, and is full-time, exempt, with an anticipated annual base salary of $120,000–$145,000, depending on qualifications and experience.

Requirements

Bachelor's degree in Regulatory Affairs, Regulatory Science, or a related scientific or technical field.
At least three years of Regulatory Affairs experience within the medical device or IVD industry.
Experience preparing regulatory documentation for FDA and international submissions.
Knowledge of applicable U.S. FDA regulations, including 21 CFR Parts 58, 809, and 820, and FDA QMSR requirements.
Knowledge of EU IVDR/IVDD requirements, including IVD classification, CE technical documentation, conformity assessments, and declarations of conformity.
Working knowledge of ISO 13485, ISO 14971, and applicable risk management guidance.
Experience with quality management systems, CAPA, audits, regulatory compliance, and design controls.
Ability to meet the professional qualification requirements to serve as PRRC under EU IVDR Article 15.
Professional knowledge and qualifications necessary to fulfill GDPR DPO responsibilities, including applicable independence and conflict-of-interest requirements.
Strong analytical, organizational, communication, and problem-solving skills.
Ability to work independently, manage multiple priorities, and collaborate effectively across departments.
Applicants must be legally authorized to work in the United States.

Nice To Haves

Five or more years of combined Regulatory Affairs and Quality Assurance experience within the medical device or IVD industry.
Direct experience managing FDA 510(k) submissions and international product registrations.
Experience preparing EU IVDR technical documentation and managing conformity assessments.
Experience with immunoassays, allergy diagnostics, or similar IVD technologies.
Previous supervisory or management experience.
Experience leading FDA inspections, notified body audits, and regulatory remediation projects.
Experience developing regulatory strategies across U.S. and international markets.

Responsibilities

Develop and implement regulatory strategies and roadmaps for pre-market and post-market activities.
Prepare, review, and manage FDA and international regulatory submissions, including 510(k), CE Marking, and EU IVDR technical documentation.
Oversee IVD product classification, conformity assessments, technical documentation, and declarations of conformity.
Evaluate the regulatory impact of product design changes, manufacturing processes, and quality system changes.
Lead regulatory aspects of design and development controls in accordance with ISO 13485 and applicable FDA QMSR requirements.
Review and approve product labeling, promotional materials, and advertising for regulatory compliance.
Communicate with regulatory authorities, notified bodies, and international agencies regarding submissions and compliance matters.
Serve as the Person Responsible for Regulatory Compliance (PRRC) under EU IVDR Article 15.
Serve as the Data Protection Officer (DPO) under GDPR, fulfilling applicable responsibilities while maintaining required independence.
Oversee the Quality Management System (QMS) for compliance with ISO 13485, FDA QMSR, and applicable international standards.
Lead internal and external audits, regulatory inspections, and corrective action activities.
Manage CAPA, nonconformance investigations, and quality improvement initiatives.
Oversee risk management activities in accordance with ISO 14971 and applicable guidance, including ISO/TR 24971.
Support complaint investigations, post-market surveillance, product recalls, and regulatory reporting.
Maintain oversight of quality documentation, change controls, and design and development activities.
Collaborate with R&D, Manufacturing, Quality Engineering, and other departments to support product quality and regulatory compliance.
Provide regulatory and quality guidance to executive management and cross-functional teams.
Supervise, mentor, and evaluate assigned personnel.
Lead interdisciplinary teams on regulatory compliance, process improvements, and operational initiatives.
Monitor departmental resources, labor costs, and budget variances.
Promote continuous improvement, accountability, and a strong culture of quality and compliance.