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Job Post Details
Regulatory Affairs Intern – Medical Devices
Regulatory Affairs Intern – Medical Devices
Job details
Full job description
Regulatory Affairs Intern – Medical Devices
Company: PlebC Innovations Private Limited
Location: Gachibowli, Hyderabad, Telangana
Job Type: Internship
Duration: 6 Months
Work Mode: On-site
Experience: Freshers / 0–1 Year
About PlebC Innovations
PlebC Innovations Private Limited is a healthcare technology startup developing innovative medical devices and robotic healthcare solutions. Our flagship technology, TORUS (Tele-Operated Robotic Ultrasound System), aims to enable remote ultrasound examinations and improve access to diagnostic healthcare.
We are looking for a motivated Regulatory Affairs Intern to support medical device regulatory documentation, quality management, compliance activities, and technical documentation.
The selected candidate will work closely with our engineering and R&D teams and gain practical exposure to regulatory processes involved in developing medical devices.
Requirements
- Pursuing or recently completed a Bachelor's or Master's degree in Biomedical Engineering, Pharmacy, Biotechnology, Life Sciences, or a related field.
- Freshers are encouraged to apply.
- Basic understanding of medical devices and their development lifecycle.
- Interest in medical device regulations, quality assurance, and compliance.
- Good written and verbal communication skills.
- Strong documentation, research, and organizational abilities.
- Attention to detail and willingness to learn.
- Ability to coordinate with multidisciplinary engineering and R&D teams.
Preferred Skills:
- Basic knowledge of ISO 13485 and ISO 14971.
- Awareness of IEC 60601, IEC 62304, and IEC 62366.
- Understanding of medical device regulatory frameworks such as CDSCO, MDR, and FDA.
- Exposure to technical writing, risk assessment, or quality documentation.
- Academic projects or internships related to healthcare technology or medical devices are an advantage.
Benefits
- Hands-on experience in medical device regulatory affairs.
- Practical exposure to ISO 13485 Quality Management Systems.
- Understanding of ISO 14971 Risk Management.
- Exposure to medical device technical files and regulatory documentation.
- Opportunity to work with engineering and R&D teams on the TORUS robotic ultrasound system.
- Learning opportunities in design controls, verification, and validation.
- Exposure to CDSCO and international medical device regulatory requirements.
- Internship completion certificate upon successful completion.
- Opportunity for full-time employment based on internship performance, skills, and organizational requirements.
- Opportunity to build a long-term career with a growing health-tech startup.
Pay: ₹10,000.00 - ₹15,000.00 per month
Work Location: In person