Aurolab Regulatory Affairs Job Opportunity | Pharma Job Opening 2026
Looking for a promising Regulatory Affairs Job in the healthcare and medical device industry? Aurolab is offering an excellent Pharma Job opportunity for candidates with experience in regulatory compliance, ISO standards, and medical device regulations. This opening is ideal for B. Pharm candidates who want to build a successful career in Regulatory Affairs and the pharmaceutical industry.
- Position: Regulatory Affairs Executive
- Location: India
About the Company
Aurolab is a reputed healthcare and medical device organization focused on quality, innovation, and global regulatory compliance. The company is known for maintaining high standards in healthcare manufacturing and regulatory excellence.
Key Responsibilities
- Understand and implement the ISO 13485, 21 CFR 820, and EU MDR regulations requirements with respect to devices.
- Executive to maintain the documents and records that comply with USFDA regulations, ISO 13485, and EU MDR requirements.
- Prepare and update the documentation for ISO 13485, EU MDR, and 510(k) submission.
- Addressing notified bodies’ queries and USFDA queries.
- Provide support for regulatory inspections and audits related to USFDA, ISO 13485, and EU MDR.
- Maintain audit reports and documentation of USFDA Audit, ISO 13485, and EU MDR audit performed.
- Collaborate with the respective Division’s QA Manager / QA Engineer / Division’s RA/Clinical team and other stakeholders.
- Assist the RA Manager.
- Ensure CAPA (Corrective and Preventive Actions) is implemented and maintained in response to audit findings.
Qualification
- Bachelor’s degree in pharmacy (B. Pharm)
- Experience: 1 – 5 years of professional experience in Regulatory Affairs within the medical device or healthcare industry.
Skills Required
- Regulatory Affairs
- ISO 13485
- EU MDR
- USFDA Regulations
- 21 CFR 820
- 510(k) Submission
- CAPA Management
- Audit Documentation
- Medical Device Compliance
Why Apply for This Pharma Job?
- Opportunity to work with a reputed healthcare and medical device company
- Exposure to international regulatory standards and compliance systems
- Strong career growth opportunities in Regulatory Affairs
- Collaborative and professional working environment
