Quality assurance regulatory affairs manager- equipments

4 weeks ago

Madurai Palace, India Aurolab Full time

KEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly operating mechanism on project status. ·Boundary less involvement in new organizational initiatives Quality Assurance: ·Capture & improve in-process yield metrics ·Final goods performance yield tracking & sustenance ·Implement non-conforming material process & resolve rework, scrap or return to vendor ·Understand parts, processes and performance ·Implement engineering change management ·Perform regular IQA ·Face the quality audits and CAPA process ·Streamline incoming parts quality & track metrics. ·Boundary less involvement in new organizational initiatives. Documentation and Reporting: ·Ensure all regulatory submissions, reports, and records are accurate, complete, and maintained according to company and regulatory standards. ·Develop and maintain technical files, dossiers, and other regulatory documents for all products. ·Prepare and present quality and regulatory reports to management. Qualifications: ·Bachelor’s degree in a scientific, engineering, or related field. Advanced degree preferred. ·8-12 years of experience in Quality Assurance and/or Regulatory Affairs in (relevant industry, e. G., pharmaceuticals, medical devices). ·Thorough knowledge of relevant regulatory guidelines (e. G., FDA, EMA, ISO standards). ·Experience with regulatory submissions and interactions with regulatory bodies. ·Strong organizational skills, with attention to detail and the ability to manage multiple projects simultaneously. ·Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams. Preferred Skills: ·Certification in Regulatory Affairs (RAC) or Quality Assurance. ·Experience with electronic quality management systems (e QMS). ·Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)

  • Quality assurance regulatory affairs manager- equipments

    1 month ago

    Madurai, India Aurolab Full time

    KEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly...

  • Quality Assurance Regulatory Affairs Manager- Equipments

    1 month ago

    madurai, India Aurolab Full time

    KEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly operating...

  • Quality Assurance Regulatory Affairs Manager- Equipments

    2 weeks ago

    madurai, India Aurolab Full time

    KEY RESPONSIBILITIES:Regulatory Affairs:·Build the technical files and drive risk management.·Understand parts, processes and performance.·Implement engineering change management.·Perform regular IQA.·Work closely with all cross-functional team members.·Review design documents & participate in periodic design reviews.·A weekly operating mechanism on...

  • Quality Assurance Regulatory Affairs Manager- Equipments

    1 month ago

    Madurai, India Aurolab Full time

    KEY RESPONSIBILITIES:Regulatory Affairs:·Build the technical files and drive risk management.·Understand parts, processes and performance.·Implement engineering change management.·Perform regular IQA.·Work closely with all cross-functional team members.·Review design documents & participate in periodic design reviews.·A weekly operating mechanism on...

  • Quality assurance regulatory affairs manager- equipments

    3 weeks ago

    Madurai, India Aurolab Full time

    KEY RESPONSIBILITIES:Regulatory Affairs:·Build the technical files and drive risk management.·Understand parts, processes and performance.·Implement engineering change management.·Perform regular IQA.·Work closely with all cross-functional team members.·Review design documents & participate in periodic design reviews.·A weekly operating mechanism on...

  • Quality Assurance Regulatory Affairs Manager- Equipments

    1 month ago

    madurai, India Aurolab Full time

    KEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly operating...

  • Quality Assurance Regulatory Affairs Manager- Equipments

    1 month ago

    Madurai, India Aurolab Full time

    KEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly operating...

  • Quality Assurance Regulatory Affairs Manager- Equipments

    1 month ago

    Madurai, India Aurolab Full time

    KEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly...

  • Quality Assurance Regulatory Affairs Manager- Equipments

    1 month ago

    Madurai, India Aurolab Full time

    KEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly operating...

  • Regulatory Affairs Specialist

    2 days ago

    Madurai, Tamil Nadu, India Aurolab Full time

    Aurolab is seeking a highly skilled Regulatory Affairs Specialist to join our team in Quality Assurance. This critical role requires comprehensive knowledge of regulatory requirements, excellent organizational skills, and the ability to work collaboratively across departments to ensure compliance with all applicable regulations.The successful candidate will...

  • Software engineer

    4 weeks ago

    Madurai Palace, India Aurolab Full time

    As a Software Engineer, you will play a critical role in the design, development, and maintenance of software for our medical equipment devices. You will collaborate with cross-functional teams, including hardware engineers, clinical experts, and regulatory specialists, to ensure our products meet the highest standards of quality and compliance. Design,...

  • Quality manager equipment

    24 hours ago

    Madurai, India Aurolab Full time

    As a Quality Manager you will be responsible for ensuring the company’s products meet all quality standards. Develop, implement, and maintain an ISO 13485-compliant Quality Management System. Work closely with all cross-functional team members & get the documentation ready for certifications and audits. Develop, review and approve the documents as per the...

  • Quality Manager Equipment

    2 days ago

    Madurai, India Aurolab Full time

    As a Quality Manager you will be responsible for ensuring the company’s products meet all quality standards. Develop, implement, and maintain an ISO 13485-compliant Quality Management System. Work closely with all cross-functional team members & get the documentation ready for certifications and audits. Develop, review and approve the documents as per the...

  • Quality Manager Equipment

    3 days ago

    Madurai, India Aurolab Full time

    As a Quality Manager you will be responsible for ensuring the company’s products meet all quality standards. Develop, implement, and maintain an ISO 13485-compliant Quality Management System. Work closely with all cross-functional team members & get the documentation ready for certifications and audits. Develop, review and approve the documents as per the...

  • Quality Manager Equipment

    3 days ago

    Madurai, India Aurolab Full time

    As a Quality Manager you will be responsible for ensuring the company’s products meet all quality standards. Develop, implement, and maintain an ISO 13485-compliant Quality Management System. Work closely with all cross-functional team members & get the documentation ready for certifications and audits. Develop, review and approve the documents as per the...

  • Quality Manager Equipment

    2 days ago

    Madurai, India Aurolab Full time

    As a Quality Manager you will be responsible for ensuring the company’s products meet all quality standards. Develop, implement, and maintain an ISO 13485-compliant Quality Management System. Work closely with all cross-functional team members & get the documentation ready for certifications and audits. Develop, review and approve the documents as per the...

  • Aurolab | Quality Manager Equipment | madurai

    3 days ago

    madurai, India Aurolab Full time

    As a Quality Manager you will be responsible for ensuring the company’s products meet all quality standards. Develop, implement, and maintain an ISO 13485-compliant Quality Management System. Work closely with all cross-functional team members & get the documentation ready for certifications and audits. Develop, review and approve the documents as per the...

  • Aurolab | Quality Manager Equipment | madurai

    3 days ago

    madurai, India Aurolab Full time

    As a Quality Manager you will be responsible for ensuring the company’s products meet all quality standards. Develop, implement, and maintain an ISO 13485-compliant Quality Management System. Work closely with all cross-functional team members & get the documentation ready for certifications and audits. Develop, review and approve the documents as per the...

  • Manager / Assistant Manager- Regulatory Affiars

    1 month ago

    Madurai, India Aurolab Full time

    The Regulatory Affairs Specialist will be responsible for preparing, managing, and coordinating regulatory submissions for USFDA (United States Food and Drug Administration) and MHRA (Medicines and Healthcare products Regulatory Agency) approvals for products manufactured at our plant. This role requires comprehensive knowledge of regulatory requirements,...

  • Manager / Assistant Manager- Regulatory Affiars

    2 weeks ago

    madurai, India Aurolab Full time

    The Regulatory Affairs Specialist will be responsible for preparing, managing, and coordinating regulatory submissions for USFDA (United States Food and Drug Administration) and MHRA (Medicines and Healthcare products Regulatory Agency) approvals for products manufactured at our plant. This role requires comprehensive knowledge of regulatory requirements,...