Achira Labs is a cutting-edge Bangalore-based company revolutionizing diagnostics with its proprietary lab-on-chip (microfluidics) technology. Their innovative platform enables rapid and reliable blood tests in near-patient settings, making healthcare more accessible and efficient.
Key Highlights of Achira Labs:
✅ Pioneering Technology: Developed India’s first microfluidics-based immunodiagnostics platform.
✅ Strong IP Portfolio: Backed by 24 international patents and multiple peer-reviewed publications.
✅ Award-Winning Innovations: Recognized with the National Technology Award (Biotechnology) and MIT’s TR35 Award.
✅ Backed by Top Investors: Supported by Catamaran and Cipla, ensuring strong financial stability.
✅ Global Collaborations: Funded by BIRAC, ICMR, DST, and Grand Challenges Canada.
Job Title: Executive – Regulatory Affairs & Quality
📍 Location: Bangalore
📌 Job Type: Full-Time
Job Description
Achira Labs is seeking a Regulatory Affairs & Quality Executive to support their mission of bringing innovative diagnostic solutions to market. This role is critical in ensuring compliance with global regulatory standards (MDR 2017, EU MDR, US FDA, CE Marking) and maintaining a robust Quality Management System (QMS).
Key Responsibilities:
✔ Prepare and submit regulatory filings, annual reports, and compliance documents.
✔ Maintain QMS documentation in line with ISO 13485, MDR 2017, and FDA QSR.
✔ Draft Clinical Evaluation Reports (CERs) for product validation.
✔ Support internal/external audits and regulatory inspections.
✔ Manage CAPA (Corrective and Preventive Actions) for product non-conformities.
✔ Collaborate with cross-functional teams to ensure compliance in labeling, claims, and process changes.
✔ Liaise with regulatory bodies and stakeholders for submissions and approvals.
Essential Qualifications:
✔ MSc in Pharma/Life Sciences or related field.
✔ 2+ years of experience in Medical Device/Pharma QA/RA.
✔ Familiarity with MDR 2017, FDA QSR, ISO 13485.
✔ Strong technical writing and documentation skills.
✔ Proficiency in MS Office (Excel, Word, PowerPoint).
Desired Competencies:
🔹 Detail-oriented with strong organizational skills.
🔹 Ability to work in a fast-paced, innovation-driven environment.
🔹 Excellent communication and stakeholder management skills.
Why Join Achira Labs?
- Work with a high-impact, award-winning med-tech team.
- Be part of cutting-edge diagnostic innovations.
- Opportunity to contribute to global healthcare solutions.
- Collaborative and innovation-driven work culture.
