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.

- Support regulatory assessments for OBLs product changes, labeling updates, and post-

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

actions/recalls.

- Maintain and update regulatory databases, tracking submissions, approvals, and renewals

on OBL products.

- Monitor and interpret evolving regulations (e.g., FDA guidance, EU MDR, ISO 13485, ISO

14971 for risk management) and communicate impacts to OBLs.

- Support post-market surveillance, including adverse event reporting and compliance with

Unique Device Identification (UDI) requirements of OBL products.

Qualifications and Requirements:

-Education: Bachelors degree in pharmacy.

- Experience: 13 years in regulatory affairs, preferably in medical devices (Class IIII),

pharmaceuticals, or a related regulated industry.

Knowledge:

- Familiarity with U.S. FDA regulations (21 CFR Parts 803, 820, 814), EU Medical Device

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

14971).

- Understanding of medical device lifecycle, including design controls, clinical data

requirements etc.

Skills:

- Strong attention to detail and organizational abilities for managing complex

documentation.

- Excellent written and verbal communication for preparing submissions and interacting with

agencies.

- Analytical mindset to evaluate regulatory risks and changes.

- Ability to work in a fast-paced, team-oriented environment.

Regulatory Affairs Associate