Regulatory Affairs Associate – Medical Devices
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
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