Regulatory & Compliance Specialist

ZipRecruiter; San Diego (CA); On-site; USD 90,000 - 95,000; Full time

Job summary

An innovative biotech organization is seeking a Regulatory & Compliance Specialist to ensure that all in vitro diagnostic products meet stringent regulatory standards. This role is crucial in collaborating with cross-functional teams to guarantee that documentation is thorough and inspection-ready. You will be responsible for guiding product development in compliance with regulations, conducting risk assessments, and preparing regulatory submissions. Join a dynamic team at the forefront of technology and global health, where your expertise will help shape the future of diagnostic solutions.

Benefits

Medical Insurance

Retirement Plan

Paid Time Off

Training & Development

Qualifications

• 3+ years in regulatory affairs or compliance in the medical device industry.
• Strong knowledge of IVD product development and FDA regulations.

Responsibilities

• Ensure compliance with FDA and ISO regulations for IVD products.
• Conduct risk assessments and support regulatory submissions.

Skills

Regulatory Affairs

Quality Assurance

FDA Regulations

ISO 13485

Analytical Skills

Problem-Solving

Communication Skills

Time Management

Education

Bachelor's degree in Life Sciences

Advanced certifications (RAC, CQE, CQA)

Job description

Job Description

Who is CorDx?

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

Job Details:

• Job Type: Full-time
• Title: Regulatory & Compliance Specialist
• Location: Onsite - San Diego
• Salary Range: $90,000 - $95,000

Position Summary:

The Regulatory & Compliance Specialist ensures development processes for all in vitro diagnostic (IVD) products comply with regulatory requirements and quality standards. This role collaborates with cross-functional teams to support product development, manufacturing, and post-market activities, ensuring documentation is complete and inspection-ready.

Key Responsibilities:

• Ensure compliance with regulations such as FDA 21 CFR Part 820 and ISO 13485.
• Provide regulatory guidance during product development to ensure compliance.
• Participate in risk management activities, maintaining risk files per ISO 14971 and FDA requirements.
• Conduct risk assessments and collaborate on risk mitigation.
• Participate in design reviews and validation activities, ensuring regulatory compliance.
• Review and approve design control documents and design history files.
• Support preparation of regulatory submissions (De Novo, 510K) for IVD products.

Requirements:

• Education: Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality Management, or related field; advanced certifications (e.g., RAC, CQE, CQA) are a plus.
• Experience: 3+ years in regulatory affairs, quality assurance, or compliance in the medical device or IVD industry; experience with 510(k) and CE marking submissions preferred.
• Skills: Strong knowledge of IVD product development, manufacturing, FDA regulations, ISO 13485; excellent communication, analytical, problem-solving, organizational, and time-management skills; high integrity and proactive compliance approach.

Benefits:

• Medical Insurance
• Retirement Plan
• Paid Time Off
• Training & Development

We are an equal-opportunity employer that values diversity and inclusion. We do not discriminate based on race, color, religion, sex, national origin, ancestry, caste, sexual orientation, gender identity, medical condition, genetic information, marital status, or military service.