qa/regulatory

Position Summary:

The QA/Regulatory Specialist is responsible for ensuring that products, services, and processes comply with internal and external quality standards, as well as government and industry regulations. This role involves maintaining documentation, conducting audits, managing regulatory submissions, and working closely with cross-functional teams to ensure that regulatory compliance is met throughout the product lifecycle.

Key Responsibilities:

1. Quality Assurance:
   • Develop, implement, and maintain quality management systems (QMS).
   • Conduct regular audits of processes, products, and services to ensure compliance with industry standards (e.g., ISO 9001, GMP).
   • Review and approve manufacturing documentation, including batch records, process validation protocols, and deviation reports.
   • Perform inspections and testing of products to ensure they meet required specifications and quality standards.
   • Monitor non-conformance reports (NCRs) and assist in implementing corrective and preventive actions (CAPA).
2. Regulatory Compliance:
   • Ensure the company complies with all applicable regulatory requirements, including FDA, EMA, ISO, and other local regulatory agencies.
   • Prepare, submit, and track regulatory filings, such as 510(k), NDA, CE mark, etc., as needed for product approval.
   • Maintain up-to-date knowledge of regulatory guidelines and standards that apply to the company's products.
   • Assist in the preparation and submission of regulatory documents, including product labeling, registrations, and licenses.
   • Support regulatory inspections and audits from governmental agencies or third parties.
3. Documentation & Reporting:
   • Maintain and organize regulatory and quality documentation, including technical files, validation reports, and regulatory submissions.
   • Prepare and review standard operating procedures (SOPs) to ensure compliance with regulatory standards.
   • Assist with the preparation of internal and external audit reports.
   • Monitor and report on key performance indicators (KPIs) related to quality and regulatory compliance.
4. Cross-Functional Collaboration:
   • Work closely with product development, manufacturing, and supply chain teams to ensure quality and regulatory compliance throughout the product lifecycle.
   • Provide guidance on regulatory issues to project teams, ensuring that regulatory requirements are met during product development.
   • Collaborate with R&D teams to support the regulatory approval process for new products or changes to existing products.
5. Training & Continuous Improvement:
   • Conduct training on regulatory and quality standards for employees at all levels of the organization.
   • Promote a culture of continuous improvement in quality management systems and regulatory compliance processes.

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, or a related field (Pharmacist).
• Proven experience in Quality Assurance and/or Regulatory Affairs, particularly in industries like pharmaceuticals, medical devices, or biotechnology.
• In-depth knowledge of FDA regulations (21 CFR Part 820, Part 11, etc.), ISO standards (e.g., ISO 13485), and other regulatory requirements.
• Strong understanding of GxP (Good Manufacturing Practices), GMP, GLP (Good Laboratory Practices), and QMS.
• Ability to interpret and apply regulatory guidelines to daily operations.
• Excellent communication, organizational, and problem-solving skills.
• Familiarity with regulatory submission processes and document control systems.
• Certification in regulatory affairs (e.g., RAC - Regulatory Affairs Certification) or quality management (e.g., CQE - Certified Quality Pharmacist) is a plus.