Regulatory Affairs & Quality Assurance Manager at Hycor in Garden Grove, California

Regulatory Affairs & Quality Assurance Manager

Location: Garden Grove, California
Employment Type: Full-Time | Exempt
Work Arrangement: On-site
Salary Range: $120,000–$145,000 annually, depending on qualifications and experience

About Hycor Biomedical

Hycor Biomedical is a global medical diagnostics company specializing in the development and commercialization of innovative in vitro diagnostic (IVD) solutions. Our products support healthcare professionals and clinical laboratories in delivering accurate and reliable diagnostic testing.

We are seeking a knowledgeable, motivated, and hands-on Regulatory Affairs & Quality Assurance Manager to join our team in Garden Grove, California.

This position offers an opportunity to lead regulatory compliance and quality assurance initiatives, collaborate with cross-functional teams, and contribute to diagnostic technologies that make a meaningful difference in patient care.

Position Summary

The Regulatory Affairs & Quality Assurance Manager will oversee and lead regulatory affairs and quality assurance activities to ensure compliance with U.S. FDA, European Union, and other applicable international regulatory requirements.

The ideal candidate will have a strong background in regulatory submissions, quality management systems, and risk management within the medical device or IVD industry.

This role requires an individual who can work independently, provide strategic regulatory guidance, and remain actively involved in day-to-day regulatory and quality activities.

Key Responsibilities

Regulatory Affairs

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 Quality Management System Regulation (QMSR) requirements.
Review and approve product labeling, promotional materials, and advertising to ensure 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.

Quality Assurance

Oversee the Quality Management System (QMS) to ensure compliance with ISO 13485, FDA QMSR, and applicable international standards.
Lead internal and external audits, regulatory inspections, and corrective action activities.
Manage Corrective and Preventive Actions (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.

Leadership & Cross-Functional Collaboration

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.

Minimum Qualifications

Bachelor's degree in Regulatory Affairs, Regulatory Science, or a related scientific or technical field.
Minimum of three (3) years of Regulatory Affairs experience within the medical device or in vitro diagnostics (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.

Preferred Qualifications

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.

Why Join Hycor Biomedical?

At Hycor Biomedical, you'll have the opportunity to contribute to diagnostic technologies that support patient care worldwide.

We offer a collaborative environment where your expertise can directly influence regulatory strategy, quality systems, and product development. You'll work alongside experienced professionals across multiple disciplines while supporting a global medical diagnostics organization.

Compensation

The anticipated annual base salary range for this position is $120,000–$145,000.

Actual compensation will be determined based on the candidate's qualifications, relevant industry experience, technical expertise, and alignment with the responsibilities of the position.

Work Authorization

Applicants must be legally authorized to work in the United States.

Equal Employment Opportunity

Hycor Biomedical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by applicable law.

Hycor Biomedical will consider qualified applicants with criminal histories in accordance with the California Fair Chance Act and applicable law.

Reasonable accommodations are available to qualified applicants and employees in accordance with applicable law.

Apply Today

If you're passionate about regulatory compliance, quality assurance, and advancing diagnostic technologies, we encourage you to apply and explore an opportunity with Hycor Biomedical.

Join our team and help support the future of diagnostic testing!