Bio Varam, a trailblazer in medical devices and advanced therapy medicinal products (ATMPs), is hiring a Regulatory Affairs, Quality Assurance, and Quality Control Specialist to join our innovative team in Hyderabad, India. If you have 5-7 years of experience in regulatory strategy, quality management systems (QMS), and compliance for medical devices, biologics, or ATMPs, this is your chance to shape the future of healthcare. Work on cutting-edge technologies like exosome-based kits, collagen scaffolds, and peptide therapeutics while ensuring adherence to Indian (CDSCO, ICMR, BIS) and global standards (FDA, EMA, ISO 13485). Apply now to join a dynamic biotech ecosystem!
Key Responsibilities
Regulatory Affairs (RA)
- Develop and implement regulatory strategies for medical devices, ATMPs, and combination products to meet CDSCO, FDA, EMA, and WHO standards.
- Prepare and submit regulatory dossiers, including IND, IDE, BLA, CE Marking, and CDSCO submissions.
- Liaise with regulatory authorities (CDSCO, DCGI, FDA, EMA) to secure clinical trial authorizations.
- Monitor and interpret evolving guidelines for cell and gene therapies, exosome products, collagen-based devices, and diagnostic kits.
Quality Assurance (QA)
- Establish and maintain ISO 13485, GMP, GLP, GDP, and GCP-compliant Quality Management Systems (QMS).
- Conduct internal and supplier audits to ensure regulatory audit readiness.
- Oversee SOP development, CAPA, deviation management, and risk assessments.
- Ensure compliance with biological safety, sterility assurance, and device validation protocols.
Quality Control (QC)
- Design and implement QC systems for biomaterials, peptides, collagen scaffolds, exosome-based kits, and medical devices.
- Oversee analytical testing, stability studies, and release criteria for R&D and GMP batches.
- Develop assay validation protocols per ICH Q2(R2) and ISO standards.
- Collaborate with R&D to scale QC methods for preclinical and clinical products.
Qualifications & Experience
- Education: Master’s degree or higher in Biotechnology, Biomedical Engineering, Regulatory Science, Life Sciences, or a related field.
- Experience: Minimum 5 years in Regulatory Affairs, QA, or QC for medical devices, biologics, or advanced therapies.
- Technical Knowledge: Expertise in ISO 13485, ISO 14971, GMP, GLP, GCP, FDA 21 CFR Part 11, ICH Q series, EU MDR, and ATMP regulations.
- Regulatory Skills: Proven experience with clinical trial submissions and interactions with CDSCO, FDA, and EMA.
- Preferred Skills: Familiarity with exosome products, collagen scaffolds, bioprinting, stem cell, or peptide therapeutics.
- Soft Skills: Detail-oriented, process-driven, excellent regulatory writing, and strong communication for liaising with regulators and cross-functional teams.
Benefits
- Join a pioneering biotech ecosystem driving world-class innovations in medical devices and ATMPs.
- Gain exposure to international collaborations and cutting-edge technologies.
- Work in a fast-paced, innovation-driven environment with opportunities for leadership and professional growth.
- Competitive salary (₹12,00,000 – ₹18,00,000 annually) and comprehensive benefits package.
How to Apply
Ready to make an impact in regulatory affairs and quality management? Send your resume and a cover letter to careers@uratpx.com with the subject line “Regulatory/QA/QC Specialist Application.” Applications are reviewed on a rolling basis, so apply by November 03, 2025, to be considered.
FAQs
Q: What qualifications are required for the Regulatory/QA/QC Specialist role?
A: A Master’s degree in Biotechnology, Biomedical Engineering, or related fields, plus 5-7 years of experience in regulatory affairs, QA, or QC for medical devices or ATMPs. Knowledge of ISO 13485, GMP, and CDSCO/FDA regulations is essential.
Q: What is the application deadline for this position?
A: The application deadline is November 03, 2025. However, we encourage early applications as we review on a rolling basis.
