Manager – Quality and Regulatory Assurance

16 hours ago

Hyderabad, Telangana, India Omicsveu Full time ₹ 12,00,000 - ₹ 36,00,000 per year

*Summary*

We are seeking a proactive and experienced Quality Assurance & Regulatory Affairs (QA/RA) Manager to lead and uphold regulatory compliance and product quality across our life sciences and IVD product lines. The ideal candidate will have a strong understanding of ISO 13485, FDA QSR/QMSR, EU IVDR, and CDSCO regulatory frameworks, and experience with FDA 510(k) submissions, EU Technical Files, and IVDR transition strategies.

*Responsibilities*


• Ensure continuous compliance with ISO 13485, US FDA QMSR, EU IVDR, and other applicable global regulations.


• Lead, develop, and maintain a comprehensive Quality Management System (QMS) covering product development, manufacturing, and distribution.


• Manage global regulatory submissions including FDA 510(k), IVDR transition project, and international product registrations.


• Provide regulatory guidance during product design, development, validation, and change management processes.


• Conduct internal audits and supplier audits; support external regulatory inspections and audits by notified bodies.


• Act as primary QA/RA liaison for the global distributor network, ensuring timely registration support and addressing compliance inquiries.


• Collaborate with cross-functional teams at USA and India locations to integrate quality and regulatory objectives with business goals.


• Stay informed about emerging trends in AI and digital health, and ensures alignment of quality and regulatory strategies with evolving technologies.

*Requirements*


• Bachelor's or Master's degree in any Science discipline (e.g., Life Sciences, Chemistry, Biotech, Biomedical Engineering).


• 5 to 8 years of professional experience in Quality Assurance / Regulatory Affairs in the medical device or IVD industry.


• Strong understanding of ISO 13485, FDA QSR/QMSR, EU IVDR, and CDSCO regulatory frameworks.


• Proven experience with FDA 510(k) submissions, EU Technical Files, and IVDR transition strategies.


• Strong analytical, organizational, and communication skills, with the ability to collaborate across international teams.


• Demonstrated ability to manage multiple priorities in a fast-paced, regulated environment.


• High adaptability to new technologies and rapidly changing regulatory environments.


• Experience using AI platforms to support quality, documentation, or regulatory functions is a strong advantage.

Requirements

  • Bachelor's or Master's degree in any Science discipline (e.g., Life Sciences, Chemistry, Biotech, Biomedical Engineering).
  • 5 to 8 years of professional experience in Quality Assurance / Regulatory Affairs in the medical device or IVD industry.
  • Strong understanding of ISO 13485, FDA QSR/QMSR, EU IVDR, and CDSCO regulatory frameworks.
  • Proven experience with FDA 510(k) submissions, EU Technical Files, and IVDR transition strategies.
  • Strong analytical, organizational, and communication skills, with the ability to collaborate across international teams.
  • Demonstrated ability to manage multiple priorities in a fast-paced, regulated environment.
  • High adaptability to new technologies and rapidly changing regulatory environments.
  • Experience using AI platforms to support quality, documentation, or regulatory functions is a strong advantage

Benefits

  • 5 day work week
  • Free Transport Facility
  • Free Insurance Coverage for family
  • PTO & Time Off
  • Flat Organization Structure

  • Assistant Quality Assurance Manager

    1 week ago

    Hyderabad, Telangana, India SK Health Care Formulation Private Limited Full time ₹ 2,50,000 - ₹ 7,50,000 per year

    Company DescriptionSK Health Care Formulation Private Limited is a biotechnology company based in Hyderabad, India. The company focuses on biotechnology and healthcare formulations.Role DescriptionThis is a full-time on-site role for a Quality Assurance Officer at SK Health Care Formulation Private Limited in Hyderabad. The Quality Assurance Officer will be...

  • Quality Assurance Auditor

    3 days ago

    Hyderabad, Telangana, India QualiTLabs Pvt Ltd Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job descriptionA Quality Auditor is responsible for ensuring that all aspects of the Company's Quality Management System adhere to regulatory standards and established quality guidelines. This role is crucial for maintaining the integrity of clinical trial data and protecting the safety of participants.Key ResponsibilitiesConducting/Host Audits: Perform...

  • Manager, Quality Assurance

    4 days ago

    Hyderabad, Telangana, India Tungsten Automation Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Tungsten Automation's Quality Assurance job family help the company to assure that its products and technology solutions are designed and built in accordance with company standards and customer requirements.A Manager, Quality Assurance provide leadership, training, coaching, and/or mentoring to one or more SQA staff members, including giving input into...

  • Quality Manager

    2 weeks ago

    Hyderabad, Telangana, India Skyquad Electronics and Appliances Private Limited, LCGC Resolute Group Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Company DescriptionSkyquad Electronics and Appliances Private Limited, Hyderabad, India .Role Descriptionfull-time on-site role for a Quality Manager located in Hyderabad. The Quality Manager will oversee daily quality assurance operations, develop and implement quality management systems, ensure compliance with industry standards, and lead continuous...

  • Manager-Development Quality Assurance

    23 hours ago

    Hyderabad, Telangana, India CIEL HR Full time ₹ 10,00,000 - ₹ 25,00,000 per year

    Role & responsibilities* Prepare and Review SOPs and Guideline for DQA.* Formulate Documentation Process for the Key divisions of SRDand ARD.* Review documents with respect to drug substance such asprotocols, SOPs, test methods, data COAs and report throughcollaborate with CRD, ARD, and QC scientists.* Successfully manage and complete all Audits that come up...

  • Quality Assurance Manager

    5 days ago

    Hyderabad, Telangana, India Experian Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Company Description Experian is a global data and technology company, powering opportunities for people and businesses around the world. We help to redefine lending practices, uncover and prevent fraud, simplify healthcare, create marketing solutions, and gain deeper insights into the automotive market, all using our unique combination of data, analytics and...

  • Quality Assurance Manager

    5 days ago

    Hyderabad, Telangana, India Experian Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Company DescriptionExperian is a global data and technology company, powering opportunities for people and businesses around the world. We help to redefine lending practices, uncover and prevent fraud, simplify healthcare, create marketing solutions, and gain deeper insights into the automotive market, all using our unique combination of data, analytics and...

  • Clinical Quality Assurance Team Member

    2 weeks ago

    Hyderabad, Telangana, India Dr Reddys Laboratories Full time ₹ 10,00,000 - ₹ 12,00,000 per year

    Team Member - Clinical DQA (Developmental Quality Assurance) Company Description Dr. Reddy's Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good...

  • Quality Assurance Principal Associate

    1 week ago

    Hyderabad, Telangana, India Eli Lilly Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Vice President Compliance Assurance GSCs Regulatory Reporting

    2 weeks ago

    Hyderabad, Telangana, India HSBC Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job DescriptionSome careers have more impact than others.If you're looking for a career where you can make a real impression, join HSBC and discover how valued you'll be.HSBC is one of the largest banking and financial services organisations in the world, with operations in 62 countries and territories. We aim to be where the growth is, enabling businesses...