Regulatory & Compliance Specialist

Job 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.

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

• 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
• 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
• Able 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
• Retail Plan
• Paid Time Off
• Training & Development