Job Description

Job Summary:

We are seeking a motivated and detail-oriented

Regulatory Affairs Executive

with 1-2 years of experience in the medical devices industry. The role involves supporting regulatory submissions, maintaining compliance with local and international regulations, and assisting in the preparation of technical documentation for product approvals and audits. This is a great opportunity for a candidate looking to grow their career in regulatory affairs within a dynamic and innovative medical device company.

Key Responsibilities:

Assist in the preparation and submission of regulatory documents for product registration and approvals (e.g., 510(k), CE Marking, CDSCO). Support the creation and maintenance of Technical Files, Design Dossiers, and product master files. Coordinate with internal teams (R&D, Quality, Manufacturing) to gather necessary documents for submissions. Monitor and interpret changes in global regulatory requirements and ensure compliance. Maintain databases and trackers for regulatory submissions, approvals, renewals, and other related activities. Assist with responding to queries from regulatory bodies and notified bodies. Help ensure that labeling, packaging, and promotional materials comply with applicable regulations. Support internal and external audits by providing relevant regulatory documents. Collaborate with senior team members to learn best practices and regulatory strategies.

Requirements:

Education:

Bachelor's degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related field.

Experience:

1-2 years of experience in Regulatory Affairs in the medical device or healthcare industry.

Skills & Knowledge:

Basic understanding of medical device regulations such as FDA 21 CFR Part 820, EU MDR 2017/745, or CDSCO. Familiarity with ISO 13485 and documentation standards. Good written and verbal communication skills. Attention to detail and strong organizational abilities. Ability to work collaboratively in a cross-functional team environment. Proficient in Microsoft Office (Word, Excel, PowerPoint).

Preferred Qualifications (Optional):

Internship or project experience related to regulatory affairs. Exposure to international regulatory submissions. Knowledge of risk management principles (e.g., ISO 14971).

Career Development:

This position offers excellent learning opportunities and career growth into roles such as

Senior Regulatory Affairs Executive

,

Regulatory Specialist

, or

Regulatory Affairs Manager

Job Type: Full-time

Pay: ₹20,000.00 - ₹38,000.00 per month

Benefits:

Health insurance Provident Fund
Work Location: In person