Regulatory Affairs Associate – Medical Devices

Company: PlebC Innovations Private Limited

Location: Hyderabad, Telangana

Job Type: Full-time

Experience: 0–1 year

Education: Bachelor’s Degree

Work Mode: On-site

Industry: Medical Devices / Healthcare Technology

About PlebC Innovations

PlebC Innovations Private Limited is a healthcare technology startup focused on developing innovative medical devices and robotic healthcare solutions. Our flagship technology, TORUS (Tele-Operated Robotic Ultrasound System), aims to enable remote ultrasound examination and improve access to diagnostic healthcare.

We are looking for a Junior Regulatory Affairs Associate who is interested in building a career in medical device regulatory affairs, quality, compliance, and technical documentation.

This is an entry-level opportunity, and freshers with a strong interest in medical devices and regulatory compliance are encouraged to apply.

Key Responsibilities

- Support the preparation and maintenance of Design History File (DHF), Device Master Record (DMR), Technical File, Risk Management File, and other regulatory documentation.
- Assist in preparing and maintaining technical and compliance documentation throughout the medical device lifecycle.
- Support compliance activities related to ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, CDSCO, MDR, and FDA 21 CFR 820.
- Work with engineering, R&D;, software, quality, and other cross-functional teams to collect technical evidence and supporting documentation.
- Assist in preparing Requirements Traceability Matrix (RTM), Verification & Validation (V&V;) documentation, test protocols, test reports, SOPs, work instructions, and other controlled documents.
- Support risk management activities, including risk analysis, hazard identification, risk controls, and risk documentation.
- Assist with design control documentation, design reviews, change control, and engineering documentation.




- Support preparation of documentation required for regulatory submissions, audits, compliance reviews, and certifications.
- Help maintain document control and ensure that regulatory and quality records are properly organized and updated.
- Assist in identifying applicable regulatory requirements and standards for medical device products.
- Support internal and external audits by preparing required records and evidence.
- Work with the technical team to understand product architecture, hardware, software, mechanical systems, and intended use.
- Assist in establishing and improving regulatory and quality documentation systems as the company scales.
- Stay updated on applicable medical device regulations, standards, and regulatory requirements.

Required Qualifications

- Bachelor’s or master's degree in pharmacy, biomedical engineering, life sciences, or a related field.
- 0–1 year of experience in medical device regulatory affairs, quality assurance, compliance, or technical documentation.
- Freshers are welcome to apply.
- Basic understanding of the medical device product lifecycle.
- Basic understanding of Quality Management Systems (QMS), risk management, design controls, and technical documentation.
- Good written and verbal communication skills.
- Strong documentation and organizational skills.
- Ability to work effectively with multidisciplinary engineering and R&D; teams.
- Willingness to learn medical device regulations, standards, and regulatory processes.

Preferred Skills

- Exposure to medical devices, healthcare technology, robotics, ultrasound systems,



or other regulated products.
- Basic familiarity with ISO 13485 and ISO 14971.
- Awareness of IEC 60601, IEC 62304, IEC 62366, or related medical device standards.
- Exposure to Verification & Validation (V&V;), Requirements Traceability Matrix (RTM), risk analysis, or design controls.
- Basic understanding of medical device software, software validation, or cybersecurity requirements.
- Familiarity with CDSCO, MDR, FDA, or other medical device regulatory frameworks.
- Experience with technical writing, documentation, or compliance-related projects.
- Internship or academic project experience in medical devices or healthcare technology will be an advantage.

What You Will Learn As part of the role, you will gain practical exposure to:

- Medical device regulatory affairs
- ISO 13485 Quality Management Systems
- ISO 14971 risk management
- Design controls and design documentation
- Verification & Validation
- Technical File and regulatory documentation
- Medical device software and hardware compliance
- CDSCO and international regulatory requirements
- Audit preparation and compliance reviews
- Regulatory documentation for innovative medical and robotic systems

Who Should Apply? This role is suitable for fresh graduates or candidates with up to 1 year of experience who want to build a career in:

- Medical Device Regulatory Affairs
- Quality Assurance
- Medical Device Compliance
- Regulatory Engineering
- Healthcare Technology
- Quality Management Systems

Candidates who are technically strong, detail-oriented, willing to learn, and interested in working in a medical-device startup environment are encouraged to apply.

Employment Details

Job Type: Full-time

Experience: 0–1 year / Freshers

Location: Hyderabad, Telangana

Work Mode: In office

Industry: Medical Devices / Healthcare Technology

Pay: ₹240,000.00 - ₹450,000.00 per year

Work Location: In person

📌 Regulatory Affairs Associate – Medical Devices (Gachibowli)
🏢 PlebC Innovations
📍 Gachibowli