Medical Device jobs in Hyderabad, Telangana

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: On-site

Industry: Medical Devices / Healthcare Technology

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

Work Location: In person