Achira Labs Hiring for Regulatory Affairs / Quality Executive
Location: Bangalore, India
Experience Required: 2 Years
Educational Qualification: M.Pharm, M.Sc, or Master’s in Medical Devices
Job Role: Executive – Regulatory Affairs & Quality
Application Mode: Online
Achira Labs, one of India’s most innovative med-tech companies, is inviting applications for the position of Executive – Regulatory Affairs & Quality. This opportunity is ideal for professionals with 2 years of experience in regulatory affairs or quality assurance within the medical device or pharmaceutical sector.
Headquartered in Bangalore, Achira Labs is well-known for its revolutionary lab-on-chip (microfluidics) diagnostic technology. The company focuses on transforming healthcare by delivering fast, reliable, and affordable diagnostic solutions in near-patient settings. Achira Labs Hiring for Regulatory Affairs / Quality Executive
About Achira Labs
Achira Labs has made a name for itself in India’s healthcare innovation ecosystem by developing the first indigenous microfluidics-based immunodiagnostics platform. The organization is driven by cutting-edge technology, a passion for innovation, and a strong commitment to making healthcare accessible and efficient. Achira Labs Hiring for Regulatory Affairs / Quality Executive
Achira Labs in Numbers:
- 24+ International Patents
- National Technology Award (Biotechnology) Winner
- MIT TR35 Award Recognition
- Backed by Leading Investors – Including Cipla and Catamaran Ventures
- Collaborations with Top Agencies – BIRAC, ICMR, DST, and Grand Challenges Canada
These accolades and partnerships reflect Achira Labs’ global credibility, making it an ideal workplace for ambitious professionals. Achira Labs Hiring for Regulatory Affairs / Quality Executive
About the Job Role – Executive (Regulatory Affairs & Quality)
Location: Bangalore
Job Type: Full-Time
Experience Required: Minimum 2 Years
Preferred Background: Medical Devices / Pharma (QA or RA)
The Regulatory Affairs & Quality Executive will play a critical role in ensuring the company’s products meet international regulatory standards, including EU MDR, US FDA, ISO 13485, and India’s MDR 2017. The role also involves managing documentation, audits, QMS activities, and regulatory submissions. Achira Labs Hiring for Regulatory Affairs / Quality Executive
Key Responsibilities
- Prepare and file regulatory submissions, annual reports, and documentation for India and global markets.
- Maintain an effective Quality Management System (QMS) aligned with ISO 13485, FDA QSR, and MDR 2017.
- Draft Clinical Evaluation Reports (CERs) to support product safety and performance.
- Participate in internal and external audits, including preparation and follow-ups.
- Handle CAPA (Corrective and Preventive Actions) processes to address product non-conformities.
- Collaborate with cross-functional teams for labeling, claims verification, and design changes.
- Liaise with regulatory authorities and external stakeholders to manage product approvals and renewals.
Eligibility Criteria
Essential Qualifications:
- Master’s degree in Pharmacy (M.Pharm), Life Sciences (M.Sc), or Medical Devices.
- Minimum 2 years of experience in Regulatory Affairs or Quality Assurance.
- Strong understanding of:
- EU MDR 2017
- FDA QSR (21 CFR Part 820)
- ISO 13485
- Hands-on experience with regulatory documentation and submission processes.
- Strong knowledge of MS Office tools like Word, Excel, and PowerPoint.
Desired Skills:
- Excellent technical writing and documentation capabilities.
- High attention to detail with a structured approach to compliance.
- Strong organizational and time-management skills.
- Excellent interpersonal and communication skills.
- Ability to work efficiently in a fast-paced, innovation-driven environment.
Why Work at Achira Labs?
Achira Labs offers a unique opportunity to work at the intersection of technology, healthcare, and innovation. Here’s why it’s a smart career move: Achira Labs Hiring for Regulatory Affairs / Quality Executive
- Innovative Work Environment: Be part of a team that is developing future-ready diagnostic technologies.
- Award-Winning Culture: Join a company that is globally recognized for its contributions to medical diagnostics.
- Professional Growth: Gain international exposure to regulatory standards and product development processes.
- Collaborative Culture: Work with engineers, scientists, clinicians, and quality experts on real-world healthcare solutions.
- Meaningful Impact: Play a vital role in shaping accessible diagnostic healthcare solutions for emerging markets.
How to Apply?
If you meet the qualifications and are passionate about healthcare innovation, apply now by submitting your resume online.
Email/Application Link: (Not provided in the brief, but assumed to be via online application through official channels) Achira Labs Hiring for Regulatory Affairs / Quality Executive
Final Thoughts
The Regulatory Affairs & Quality Executive position at Achira Labs is a promising career opportunity for mid-level professionals in the med-tech and pharmaceutical sectors. With the backing of major investors and recognition from global institutions, Achira offers both job security and cutting-edge experience. Achira Labs Hiring for Regulatory Affairs / Quality Executive
If you’re looking for a workplace that challenges your expertise and rewards your contribution to meaningful innovations in healthcare, Achira Labs is the right place for you.
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