Role: Regulatory Affairs / Quality Assurance / Quality Control Specialist
Company: Bio Varam
Location: Hyderabad
Education: Master’s degree in Biotechnology, Biomedical Engineering, Regulatory Science, or Life Sciences
Experience: 5–7 years
Job Type: Full-Time (Onsite)
Status: Verified Job
About the Role
Bio Varam, a pioneer in medical devices and advanced therapy medicinal products (ATMPs), is seeking a Regulatory Affairs, Quality Assurance, and Quality Control Specialist to join its innovative team in Hyderabad. Regulatory Affairs/ QA/ QC Specialist Jobs at Bio Varam
This role offers the opportunity to work with cutting-edge healthcare technologies such as exosome-based kits, collagen scaffolds, peptide therapeutics, and ATMPs while ensuring compliance with Indian and global regulatory frameworks.
Key Responsibilities
Regulatory Affairs (RA):
- Develop regulatory strategies for medical devices, ATMPs, and biologics per CDSCO, FDA, EMA, and WHO requirements.
- Prepare and file submissions: IND, IDE, BLA, CE Marking, and CDSCO applications.
- Liaise with regulatory authorities for approvals and clinical trial authorizations.
- Track evolving regulations for exosome products, collagen devices, and diagnostic kits.
- Regulatory Affairs/ QA/ QC Specialist Jobs at Bio Varam
Quality Assurance (QA):
- Maintain QMS compliance with ISO 13485, GMP, GLP, GDP, and GCP standards.
- Conduct internal & supplier audits for regulatory readiness.
- Manage SOPs, CAPA, deviations, and risk assessments.
- Oversee validation and sterility assurance processes.
Quality Control (QC):
- Design QC systems for peptides, biomaterials, collagen scaffolds, and exosome-based kits.
- Supervise analytical testing, stability studies, and product release.
- Develop assay validation methods per ICH Q2(R2) and ISO standards.
- Collaborate with R&D for clinical and preclinical QC scaling.
Qualifications
- Education: Master’s or higher in Biotechnology, Biomedical Engineering, Regulatory Science, or Life Sciences.
- Experience: 5–7 years in RA/QA/QC for medical devices, biologics, or ATMPs.
- Technical Knowledge: ISO 13485, ISO 14971, GMP, GLP, GCP, FDA 21 CFR Part 11, ICH Q series, EU MDR, ATMP frameworks.
- Skills: Strong regulatory writing, risk-based approach, excellent communication, cross-functional collaboration.
- Preferred Expertise: Exosome products, collagen scaffolds, stem cells, peptides, or bioprinting technologies.
- Regulatory Affairs/ QA/ QC Specialist Jobs at Bio Varam
Benefits
- Competitive annual salary: ₹12,00,000 – ₹18,00,000
- Professional growth in a global biotech ecosystem
- Exposure to international collaborations and regulatory interactions
- Leadership opportunities in a high-paced, innovation-driven workplace
- Comprehensive benefits package
How to Apply
Interested candidates should send their resume and cover letter to: Regulatory Affairs/ QA/ QC Specialist Jobs at Bio Varam
📧 careers@uratpx.com
Subject Line: Regulatory/QA/QC Specialist Application
Deadline: November 03, 2025 (applications reviewed on a rolling basis, early applicants preferred).
FAQs
Q: What qualifications are required?
A: A Master’s degree in Biotechnology, Biomedical Engineering, or related fields with 5–7 years of RA/QA/QC experience in medical devices, biologics, or ATMPs.
Q: What is the application deadline?
A: November 03, 2025. Early applications are encouraged.
👉 Apply now and contribute to shaping the future of advanced therapies with Bio Varam. Regulatory Affairs/ QA/ QC Specialist Jobs at Bio Varam
