Regulatory & Compliance Specialist

Job Description

Job Description

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 & Compliance Specialist
Location: Onsite - San Diego

Salary Range: $90,000 - $95,000

Position Summary:

The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro diagnostic (IVD) products comply with applicable regulatory requirements and quality standards. This role will work closely with cross-functional teams to support product development, manufacturing, and post-market activities. The specialist will ensure that all documentation and files related to diagnostic development are completed in a timely manner and are ready for inspections.

Key Responsibilities:

• Ensure compliance with regulatory requirements for In Vitro Diagnostic products, FDA 21 CFR Part 820, ISO 13485.
• Provide regulatory guidance during the product development process, ensuring that products are designed and developed in compliance with applicable regulations.
• Participate in risk management activities, including the development and maintenance of risk management files according to ISO 14971 and FDA 21 CFR Part 820.
• Conduct risk assessments and work with product development teams to mitigate identified risks.
• Participate in design reviews meetings and validation activities, ensuring that regulatory and quality requirements are met.
• Review and approve design control documentation, including design input and output, design verification and validation protocols, ensuring that all documentation meets regulatory requirements.
• Review and approve design history file for each new product.
• Support preparation of internal quality and regulatory documents in support of regulatory submission (De Novo and 510K) for IVD products.

Requirements

• Education:
• Bachelor's degree in a related field (e.g., Life Sciences, Engineering, Regulatory Affairs, Quality Management) or equivalent experience.
• Advanced degree or certification in Regulatory Affairs (e.g., RAC) or Quality Management (e.g., CQE, CQA) is a plus.
• Experience:
• 3+ years of experience in regulatory affairs, quality assurance, or compliance within the medical device or In Vitro Diagnostics industry.
• Experience with regulatory submissions, including 510(k) and CE marking, is highly preferred.
• Strong knowledge of global regulatory standards, including FDA regulations and ISO 13485.
• Skills:
• Strong understanding of IVD product development and manufacturing processes.
• Excellent written and verbal communication skills
• Strong analytical and problem-solving skills, with attention to detail and accuracy.
• Ability to work independently and as part of a team, with strong organizational and time-management skills.
• High level of integrity and commitment to upholding regulatory and quality standards.
• Proactive approach to identifying and addressing compliance risks and issues.

Benefits

• Medical Insurance Plan
• Retirement Plan
• Paid Time Off

• Training & Development
  We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.