Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
About the role
- Regulatory Specialist ensuring medical devices comply with international regulations. Preparing documentation and supporting certification processes in a hybrid role at Medline.
Responsibilities
- Ensure all medical devices comply with international and local regulatory requirements.
- Prepare and maintain technical documentation, supporting product certification processes
- Carry out post‑market surveillance activities to uphold regulatory standards.
- Drive regulatory strategy and ensure compliance with EU MDR, ISO 13485, and global regulations.
- Serve as the main regulatory contact for distributors, partners, and competent authorities.
- Lead PMS activities to ensure products meet local requirements.
- Manage distributors and support audits for market compliance.
- Prepare essential regulatory documentation (STED, PMS reports, risk files).
- Collaborate with R&D, Quality, Supply Chain, Marketing, and Operations across the product lifecycle.
- Provide regulatory guidance for product changes and market expansions.
- Support CE marking and ISO audits with competent authorities.
- Monitor global regulatory changes and update internal processes proactively.
- Maintain supplier records and regulatory product database.
- Contribute to internal audits and manage documentation.
Requirements
- University Degree in Sciences or Engineering specialized in Regulatory Affairs
- Good written and oral communication in English.
- Positive attitude, results oriented
- Leadership experience
- Good knowledge of continuous improvement tools – Greenbelt/5S
Benefits
- Annual bonus of 7% of gross annual salary, paid twice a year based on KPI performance
- Transportation allowance
- Seniority bonus
- Meal allowance in the cafeteria
- Financial reward for improvement suggestions
Job title
Job type
Experience level
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