Job Title: Regulatory Affairs Quality Assurance (RA QA) SpecialistLocation: Okhla- Phase-1Company: Devine Meditech
About Devine Meditech:
Devine Meditech is a leading innovator in the medical device industry, specializing in advanced healthcare solutions that improve patient care and outcomes. We are committed to ensuring compliance with global regulatory standards while maintaining the highest quality assurance standards for all our products. We are seeking a talented and detail-oriented Regulatory Affairs Quality Assurance (RA QA) Specialist to join our dynamic team.
Job Summary:
The RA QA Specialist will play a key role in ensuring the compliance of our products with international regulatory requirements and quality standards. This role combines regulatory affairs expertise with quality assurance responsibilities to support the development, manufacturing, and distribution of safe and effective medical devices.
Key Responsibilities:
- Regulatory Affairs:
- Prepare, review, and submit regulatory documents to obtain and maintain product approvals from global regulatory agencies (e.g., FDA, CE, ISO).
- Monitor regulatory changes and ensure compliance with local and international regulatory standards.
- Provide guidance on regulatory requirements for new and existing products.
- Liaise with regulatory authorities and provide responses to inquiries or requests.
- Maintain regulatory files and documentation to ensure product compliance.
- Quality Assurance:
- Ensure adherence to the company's Quality Management System (QMS), including ISO 13485 and FDA regulations.
- Perform internal audits, inspections, and assessments of manufacturing processes, design controls, and product documentation.
- Collaborate with cross-functional teams (R&D, manufacturing, and marketing) to ensure quality and regulatory requirements are met throughout the product lifecycle.
- Support the resolution of quality issues and deviations, ensuring appropriate corrective and preventive actions (CAPA) are implemented.
- Assist in the preparation for external audits and inspections.
- Documentation and Reporting:
- Ensure all regulatory and quality documentation is accurate, complete, and up-to-date.
- Maintain detailed records of regulatory filings, approvals, and QA inspections.
- Prepare periodic compliance and audit reports for senior management.
Qualifications:
- Bachelor's degree in a related field (e.g., Life Sciences, Engineering, or Regulatory Affairs).
- At least 5-6 years of experience in regulatory affairs and quality assurance in the medical device industry.
- In-depth knowledge of FDA, CE Marking, and ISO 13485 regulations.
- Strong understanding of medical device product development, design controls, and risk management processes.
- Experience with internal and external audits, CAPA processes, and product lifecycle management.
- Familiarity with regulatory submission processes for both domestic and international markets.
- Excellent communication, organizational, and problem-solving skills.
- Strong attention to detail and ability to work under pressure.
Preferred Qualifications:
- Regulatory Affairs Certification (RAC) or Quality Auditor Certification (CQA) preferred.
- Experience with medical device software or combination products.
- Knowledge of global regulatory requirements (e.g., Canada, Japan, Australia).
Why Devine Meditech
- Join a forward-thinking company committed to improving global healthcare.
- Collaborative and dynamic work environment.
- Competitive compensation and benefits package.
- Opportunities for professional growth and development.
If you are a motivated and detail-oriented professional with a passion for regulatory compliance and quality assurance in the medical device industry, we encourage you to apply!
- This job description is a general overview of typical responsibilities and requirements for an RA QA role at a company like Devine Meditech. It can be customized based on specific company needs or job expectations.
