Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)

CorDx; San Diego (CA); Presencial; CAD 168.000 - 223.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive compensation

Medical, dental, and vision insurance

401(k) plan

Flexible paid time off (PTO)

Additional substantial benefits

Descripción de la vacante

CorDx is seeking a Regulatory Affairs Manager to lead regulatory submissions and risk assessment for medical device products. You will coordinate 510(k) submissions, technical files, and regulatory documentation across functions to secure approvals and clearances.

You will liaise with FDA and other authorities, ensure compliance with FDA 21 CFR Part 820 and ISO 13485, and guide product teams through lifecycle regulatory needs, audits, and documentation workflows.

Formación

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required.
• Master’s degree preferred.
• 5–7 years of regulatory affairs experience within the medical device or IVD industry.
• Experience with FDA 510(k) submissions and regulatory documentation processes.
• Experience interacting with FDA and other regulatory agencies preferred.

Responsabilidades

• Prepare, review, and coordinate the submission of regulatory documents including 510(k), technical files, and other filings to regulatory agencies.
• Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards.
• Provide regulatory guidance to product development teams.
• Stay current on regulatory changes and assess impact on processes.
• Maintain documentation of all regulatory submissions and correspondence.
• Support regulatory agency meetings, audits, and inspections.
• Collaborate with R&D, Quality, and Operations to meet regulatory deliverables.

Conocimientos

FDA regulations 21 CFR 820

ISO 13485

Regulatory submissions

Cross-functional collaboration

Educación

Bachelor’s degree in Regulatory Affairs or related field

Master’s degree preferred

Descripción del empleo

Who is CorDx？

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Job Type: Full time
Job Title: Regulatory Affairs Manager
Location: Onsite - San Diego, CA

Position Summary:

The Regulatory Affairs Manager will support the preparation, review, and submission of regulatory documentation for medical device products, ensuring compliance with applicable regulatory requirements including FDA, ISO 13485, and other global standards. This position collaborates with cross-functional teams to provide regulatory input during product development and throughout the product lifecycle, helping to secure timely product approvals and regulatory clearances.

Key Responsibilities:

• Prepare, review, and coordinate the submission of regulatory documents including 510(k), technical files, and other filings to regulatory agencies.
• Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards.
• Provide regulatory support to product development teams by offering guidance on applicable regulations and documentation requirements.
• Stay current on changes in regulatory requirements and assist in assessing the impact on company processes and products.
• Perform regulatory assessments for product changes and propose appropriate regulatory pathways.
• Maintain documentation and records of all regulatory submissions and correspondence.
• Support the preparation for regulatory agency meetings, audits, and inspections.
• Collaborate with internal departments such as R&D, Quality, and Operations to ensure regulatory deliverables are met in a timely manner.

Requirements

Education:

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required.
• Master’s degree preferred.

Professional Experience:

• 5–7 years of regulatory affairs experience within the medical device or IVD industry.
• Working knowledge of 510(k) submissions and regulatory documentation processes.
• Experience interacting with FDA and other regulatory agencies preferred.

Skills & Competencies:

• Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, and medical device regulatory requirements.
• Strong organizational and project management skills with the ability to manage multiple projects and priorities.
• Excellent communication, problem-solving, and attention to detail.
• Ability to work collaboratively in cross-functional teams and manage document workflows.

Benefits

• Highly competitive compensation package.
• Comprehensive medical, dental, and vision insurance.
• 401(k) plan with generous company contributions.
• Flexible paid time off (PTO) policy.
• Additional substantial benefits.

Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.