Hiring: Regulatory Affairs Associate – Medical Devices | APACExperience: 2–3 Years | Location: Bengaluru

We are looking for a motivated and detail-oriented Regulatory Affairs Associate with 2–3 years of relevant experience in the medical device industry to join our team in Bengaluru.

The selected candidate will support regulatory activities for active and passive medical devices, including product registrations, technical documentation, regulatory submissions, compliance assessment, and coordination with regulatory authorities and internal product-development teams.

This role offers an opportunity to gain broader exposure to Indian and Asia-Pacific (APAC) medical device regulatory requirements and participate in the complete regulatory lifecycle of medical devices.

Key Responsibilities• Support preparation, compilation, review, and submission of regulatory dossiers for medical device registrations in India and APAC markets.

- Prepare and maintain documentation required for applications and submissions to CDSCO – Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017.
- Support activities related to:

- Medical device registration and licensing
- Import/manufacturing licence applications
- Product classification
- Device Master File / technical documentation
- Plant Master File documentation
- Regulatory renewals, amendments, and change notifications
- Responses to regulatory authority queries

• Assist in preparation and review of technical documentation for active and passive medical devices, including:

- Device description and intended use
- Product specifications
- Design and manufacturing information
- Essential Principles / General Safety and Performance Requirements
- Risk-management documentation
- Verification and validation documentation
- Clinical / performance evaluation documentation
- Labelling, IFU, packaging, and artwork review

• Support compliance activities associated with applicable international standards, including relevant requirements of:
- IEC 60601 series for electrical medical equipment
- IEC 60601-1 – Basic Safety and Essential Performance
- IEC 60601-1-2 – Electromagnetic Compatibility
- Applicable IEC 60601-2-x particular standards
- IEC 62304 – Medical Device Software Lifecycle Processes
- IEC 62366 / IEC 62366-1 – Usability Engineering
- ISO 14971 – Medical Device Risk Management
- ISO 13485 – Medical Device Quality Management Systems
- ISO 10993 series – Biological Evaluation of Medical Devices,



where applicable

• Review test reports and technical evidence generated by laboratories, suppliers, engineering teams, and external regulatory consultants.
- Work closely with R&D;, Hardware, Firmware, Software, Quality Assurance, Manufacturing, Clinical, and Product Management teams to ensure regulatory requirements are incorporated into product development.
- Support regulatory strategy and submission planning for selected APAC markets, including understanding country-specific classification, registration pathways, documentation, local representative requirements, and post-market obligations.
- Maintain regulatory submission trackers, licence databases, product-registration records, certificates, authority correspondence, and controlled regulatory documents.
- Monitor changes in applicable medical device regulations, guidance documents, standards, and regulatory expectations and communicate potential impact to relevant internal teams.
- Support post-market regulatory activities, including:

- Complaint and vigilance documentation
- Adverse-event reporting support
- Field safety corrective actions, where applicable
- Regulatory impact assessment for product/design changes
- Registration maintenance and renewals

Required QualificationBachelor's or Master's degree in one of the following or a related discipline: Biomedical Engineering / Electronics / Electrical Engineering / Pharmacy / Biotechnology / Life Sciences / Medical Electronics / Regulatory Affairs

Experience2–3 years of hands-on Regulatory Affairs experience, preferably within the medical device industry.

Candidates should have practical exposure to at least some of the following:

- CDSCO medical device regulations
- Medical Devices Rules, 2017
- Medical device dossier preparation
- Technical documentation
- Product registration
- Active medical devices
- Passive / non-active medical devices
- IEC and ISO medical-device standards
- Regulatory submission coordination

Preferred Knowledge & SkillsStrong working knowledge or exposure to:

Indian Regulatory

- CDSCO
- Medical Devices Rules, 2017




- Device classification and licensing pathways
- Import and manufacturing licence documentation

International / APAC Regulatory Exposure to regulatory requirements in one or more APAC markets such as:

- Australia – TGA
- Singapore – HSA
- Malaysia – MDA
- Thailand – Thai FDA
- Indonesia
- Philippines
- Vietnam
- Other Asia-Pacific medical device markets

Standards & Compliance

- ISO 13485
- ISO 14971
- IEC 60601 series
- IEC 62304
- IEC 62366-1
- ISO 10993, where applicable

Knowledge of EU MDR, CE marking, US FDA 510(k), IMDRF documentation principles, or MDSAP will be considered an added advantage. Candidate ProfileWe are looking for someone who:

- Has good understanding of medical-device regulatory documentation
- Can independently compile and organise regulatory dossiers
- Has strong documentation and technical-writing skills
- Can interpret regulatory guidelines and international standards
- Is comfortable coordinating with engineering and quality teams
- Has good attention to detail and document-control discipline
- Can manage multiple regulatory submissions and timelines
- Has strong written and verbal communication skills
- Is eager to develop expertise across multiple international markets

Why Join Us?This position provides an chance to work closely with medical device product development, quality systems, compliance, and international regulatory activities. You will gain exposure to both active and passive medical devices and participate in regulatory activities spanning India and APAC markets, helping build valuable global regulatory expertise.

Position DetailsPosition: Regulatory Affairs Associate – Medical Devices

Experience: 2–3 Years

Location: Bengaluru, Karnataka

Employment: Full-Time

Industry: Medical Devices / Healthcare Technology

Function: Regulatory Affairs / Quality & Regulatory

How to ApplyInterested candidates may apply with their updated resume highlighting their experience in:

CDSCO | Medical Device Registration | Technical Documentation | IEC 60601 | ISO 13485 | ISO 14971 | APAC Regulatory Affairs | Active & Passive Medical Devices

Applications from candidates with hands-on medical-device dossier preparation and regulatory submission experience are particularly encouraged.

#Hiring #RegulatoryAffairs #MedicalDevices #CDSCO #MedicalDeviceRegulatory #APAC #IEC60601 #ISO13485 #ISO14971 #BiomedicalEngineering #BengaluruJobs #RegulatoryJobs #HealthcareJobs

📌 Regulatory Affairs Associate – Medical Devices | APAC (Bengaluru)
🏢 Aria Innovations Private
📍 Bengaluru