Reglysis specializes in providing comprehensive, reliable, and innovative regulatory solutions for the life sciences industry. Our expertise covers medical devices, pharmacovigilance, and regulatory affairs, ensuring compliance with global regulatory frameworks.
We are looking for a Regulatory Affairs Specialist to help drive compliance and regulatory strategy across multiple markets.
Job Description
As a Regulatory Affairs Specialist, you will be responsible for preparing and submitting regulatory documents, collaborating with cross-functional teams, and staying up-to-date with evolving regulatory landscapes.
Key Responsibilities
- Regulatory Submissions: Prepare and submit regulatory documents such as 510(k), PMA, CE Marking, IND, NDA, and MAA.
- Compliance: Ensure adherence to FDA, EMA, MDR, IVDR, ISO 13485, ICH, and other regulatory guidelines.
- Technical Documentation: Develop technical files, risk assessments, and regulatory strategies for product approvals.
- Regulatory Interaction: Communicate with global health authorities to address queries and obtain approvals.
- Risk Monitoring: Track adverse events, recalls, and regulatory updates to ensure continued compliance.
- Cross-Functional Collaboration: Work closely with R&D, Quality, and Clinical teams to support regulatory needs.
Work Location
- Hyderabad, India
How to Apply
- Send your resume to info@reglysis.com
For more information, visit www.reglysis.com.
Join Reglysis and be part of a team that ensures global regulatory excellence!