Quality Assurance and Regulatory Specialist

Job Summary:

The Quality Assurance (QA) Specialist ensures that biomedical products, research processes, and regulatory compliance align with industry standards and client requirements. Key roles in this position include reviewing documentation, conducting audits, and advising clients on quality management systems (QMS), regulatory compliance (FDA, ISO, GMP), and risk mitigation strategies.

Key Responsibilities:

• Develop, implement, and maintain quality assurance protocols and SOPs for biomedical products, research, and consulting services.
• Conduct internal and client audits to ensure compliance with FDA, ISO 13485, GMP, and other regulatory standards.
• Review and validate clinical research protocols, medical device documentation, and product testing processes.
• Assist clients with applications for drug and medical device submissions
• Provide guidance to clients on NDA, ANDA, PMA,
• Assist in the development and implementation of Quality Management Systems (QMS) for clients.
• Provide regulatory guidance on risk management, good documentation practices, and process improvement strategies
• Collaborate with cross-functional teams (R&D, regulatory affairs, manufacturing) to resolve quality-related issues.
• Monitor and analyze quality metrics, identifying trends and areas for improvement.
• Support the development of Standard Operating Procedures (SOPs) and training materials.
• Investigate non-conformities (NCs) and corrective/preventive actions (CAPA) to ensure compliance and continuous improvement.
• Stay updated on industry regulations, emerging trends, and best practices in biomedical quality assurance.

Qualifications & Skills:

• Bachelor’s degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field (Master’s preferred).
• 6 years of experience in quality assurance, regulatory compliance, or consulting within the biomedical, medical device, or pharmaceutical industry.
• Familiarity with FDA regulations (21 CFR 820, 21 CFR 211, 21 CFR 11), ISO 13485, GMP, and risk management standards.
• Good understanding of medical device lifecycle, clinical trials, and validation processes.
• Experience with document control systems, QMS software, and compliance tracking tools.
• Excellent analytical, problem-solving, and communication skills.
• Ability to interpret and apply regulatory guidelines effectively in consulting projects.

Preferred Qualifications:

• Certifications such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Regulatory Affairs Certification (RAC) are a plus.