Regulatory Affairs Associate

Job Summary :

A Regulatory Affairs Associate in the medical device industry supports the development,

registration, and compliance of medical devices throughout their lifecycle. This entry-to-mid-

level role ensures products meet regulatory standards set by bodies such as the FDA (U.S.),

EU MDR (Europe), and other international authorities. The associate works closely with

cross-functional teams (e.g., R&D, Quality Assurance, Clinical, and Marketing) to prepare

submissions, maintain documentation, and monitor regulatory changes, contributing to safe

and timely market access for medical devices.

Key Responsibilities :

• Assist in preparing, reviewing, and submitting regulatory documents, Technical

Files / Dossiers for CE marking, and international registrations (e.g., for Canada, Australia, or

emerging markets including 510(k) premarket notifications, Premarket Approval (PMA)

applications.

market activities, such as Medical Device Reporting (MDR), vigilance reporting, and field

actions / recalls.

on OBL products.

14971 for risk management) and communicate impacts to OBLs.

Unique Device Identification (UDI) requirements of OBL products.

Qualifications and Requirements :

pharmaceuticals, or a related regulated industry.

Knowledge :

Regulation (MDR 2017 / 745), MDSAP, and international standards (e.g., ISO 13485, ISO

14971).

requirements etc….

Skills :

documentation.

agencies.