Medical Device Regulatory Affairs Intern

2 weeks ago

Pappanaickenpalayam Coimbatore Tamil Nadu, India B-Arm Medical Technologies Private limited Full time

**Job Title: Medical Device Regulatory Affairs Intern**

**Overview**

As a Medical Device Regulatory Affairs Intern, you will support managing the regulatory processes for medical devices. You will assist in preparing documentation, conducting research, and ensuring compliance with regulatory requirements. This internship provides a valuable opportunity to learn about regulatory affairs in the medical device industry and gain practical experience in a supportive environment.

**Responsibilities**:

- Support the regulatory affairs team in the review of design documentation
- Research device product specifications and regulatory requirements for domestic launches
- Review international and domestic requirements for product launches in R&D pipeline
- Assist in collecting data, information and reports needed for the completion of product registration
- Conduct research on regulatory requirements and guidelines for different markets to support submission strategies and compliance.
- Maintain and organize regulatory documentation and track submission status and deadlines.
- Assist in monitoring and reporting on the performance of medical devices in the market to ensure ongoing compliance.
- Identify and mitigate the risks associated with the unregulated sale of medical devices on online platforms. Work closely with regulatory bodies, marketplace operators, and internal teams to ensure that all devices sold online comply with applicable laws and regulations.
- Handle diverse operational matters as needed, contributing to the overall efficiency of the regulatory affairs team.

**Job Requirements**:

- Knowledge of Microsoft Word, Excel and Adobe preferred
- Highly organized and detail-oriented
- Proactive team player, able to take charge and follow-through
- Ability to work independently and as part of a team

**Education**:Bachelors or Master’s degree in a related field, such as Biomedical Engineering, Biology, Chemistry or Health Sciences

**Salary**: INR 10,000 Per Month

**Job Type**: 6 Months Internship.

**Salary after 6 Months**: 3-4 Lakhs PA (Performance based)

Pay: ₹10,000.00 per month

Schedule:

- Day shift

Work Location: In person

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