Are you a pharmacy, biotechnology, life sciences, biomedical engineering, or medical technology graduate looking to start your career in Medical Device Regulatory Affairs and Quality Assurance? DGN Technologies Inc. has an opportunity for an RAQA Specialist – Regulatory Affairs in Bangalore, Karnataka.
The position is suitable for freshers and candidates with up to 2 years of experience who want to develop practical knowledge of regulatory submissions, medical device compliance, quality systems, and technical documentation.
DGN Technologies RAQA Specialist Recruitment 2026 – Job Details
| Particular | Details |
|---|---|
| Company | DGN Technologies Inc. |
| Position | RAQA Specialist – Regulatory Affairs |
| Department | Regulatory Affairs & Quality Compliance |
| Location | Bangalore, Karnataka |
| Experience | Fresher / 0–2 Years |
| Employment Type | Contract Basis |
| Industry | Medical Devices / Healthcare |
| Work Area | Regulatory Affairs & Quality Assurance |
About the RAQA Specialist Role
Regulatory Affairs and Quality Assurance professionals help medical device companies maintain compliance with applicable regulations and quality requirements. The role can involve preparing regulatory documentation, reviewing product information, supporting registrations, and coordinating quality-related activities.
As an RAQA Specialist, the selected candidate may work with regulatory and quality teams to organize technical information and ensure that documentation is prepared accurately for applicable regulatory requirements.
Key Responsibilities
1. Regulatory Documentation
The role may involve collecting and maintaining technical documents, testing information, quality records, and other materials required for regulatory submissions.
2. Compliance Review
Candidates may assist in reviewing product labels, packaging information, instructions for use (IFU), and related documentation for regulatory compliance.
3. Quality Management Support
The position can provide exposure to quality management activities, including document control, internal quality processes, risk management, and CAPA-related activities.
4. Product Registration Support
The selected candidate may assist regulatory teams with product registration activities and learn how medical devices are prepared for submission to regulatory authorities.
5. Cross-Functional Coordination
RAQA professionals often work with technical, quality, engineering, documentation, and other internal teams to collect information needed for regulatory and compliance activities.
Educational Qualification
Candidates from relevant pharmaceutical, life science, engineering, and healthcare backgrounds may be considered.
Relevant qualifications include:
- B.Pharm / M.Pharm
- B.Sc / M.Sc in Biotechnology
- B.Sc / M.Sc in Microbiology
- B.Sc / M.Sc in Chemistry
- B.Sc / M.Sc in Life Sciences
- B.Tech / M.Tech in Biomedical Engineering
- B.Tech / M.Tech in Biotechnology
- Medical Technology and related healthcare disciplines
Fresh graduates with relevant academic projects, internships, or additional training in regulatory affairs may find this opportunity particularly relevant.
Skills Required for Medical Device Regulatory Affairs
1. Understanding of Medical Device Regulations
Candidates should have a basic understanding of medical device classification, safety requirements, regulatory submissions, and market authorization concepts.
2. CDSCO and Medical Devices Rules
Knowledge of India’s medical device regulatory framework can be useful. Candidates should ideally be familiar with concepts covered under Medical Devices Rules, 2017, including device classification and regulatory requirements.
3. ISO 13485 and Quality Systems
Basic knowledge of ISO 13485 and medical device Quality Management Systems can help candidates understand document control, quality processes, risk management, and CAPA.
4. Regulatory Documentation
Applicants should be comfortable working with technical documents and maintaining organized records. Familiarity with product labels, packaging information, IFUs, and regulatory dossiers can be an advantage.
5. MS Office
Basic proficiency in:
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
can be useful because regulatory roles involve considerable documentation, data tracking, and reporting.
Is This Job Suitable for Freshers?
Yes. According to the information provided, the position accepts candidates with 0–2 years of experience, making it relevant to both fresh graduates and early-career professionals.
Freshers can strengthen their profile by demonstrating:
- Academic projects related to medical devices
- Regulatory Affairs internships
- Knowledge of CDSCO requirements
- Basic understanding of Medical Devices Rules, 2017
- ISO 13485 awareness
- Knowledge of medical device risk classification
- Good documentation skills
- Strong written communication
Why Consider a Career in Medical Device Regulatory Affairs?
Medical device regulatory affairs combines healthcare, science, documentation, quality systems, and regulatory compliance.
Starting in an entry-level RAQA role can provide exposure to areas such as:
- Medical device registration
- Regulatory submissions
- Quality Management Systems
- Technical documentation
- Risk management
- Labeling compliance
- Regulatory intelligence
- International regulatory requirements
With experience, professionals can explore opportunities in areas such as US FDA regulations, European medical device regulations, international registrations, quality assurance, audits, and regulatory consulting.
How Freshers Can Prepare for the Interview
Recommended Regulatory Affairs Course: Certification in Drug Regulatory Affairs & Medical Devices – Udemy `
Candidates applying for entry-level RAQA positions should revise the fundamentals before an interview.
Important topics to study include:
- What is Regulatory Affairs?
- What is a medical device?
- Medical device classification in India
- Basic concepts of CDSCO
- Medical Devices Rules, 2017
- Purpose of ISO 13485
- Difference between QA and QC
- What is CAPA?
- What is risk management?
- What is document control?
- What is an IFU?
- What is a regulatory dossier?
- Basics of medical device labeling
- Difference between pharmaceutical and medical device regulations
Candidates should also be prepared to explain any academic project, internship, certification, or regulatory-related coursework mentioned on their CV.
How to Apply for DGN Technologies RAQA Specialist Vacancy
Interested candidates can submit their updated CV to the recruitment contact provided in the job information.
Contact Person: Shubham S. Thakare
Organization: DGN Technologies Inc.
Email: sthakare@dgntechnologies.com
Cell / WhatsApp: +91 8551995176
Recommended Regulatory Affairs Course: Certification in Drug Regulatory Affairs & Medical Devices – Udemy
When applying, candidates should mention the RAQA Specialist – Regulatory Affairs position in their email subject/message and include a concise introduction.
If you have completed an internship, certification, or academic project related to Regulatory Affairs, medical devices, CDSCO, ISO 13485, or Quality Management Systems, highlight it clearly in your application.
Final Thoughts
The DGN Technologies RAQA Specialist opening in Bangalore is aimed at candidates interested in building an early-career path in medical device regulatory affairs and quality compliance. Candidates from pharmacy, biotechnology, life sciences, biomedical engineering, and related backgrounds can review the eligibility requirements and apply using the recruitment contact provided above.
Before applying, make sure your CV clearly highlights your educational qualification, relevant internships, regulatory coursework, technical projects, and knowledge of medical device regulations.
Disclaimer: This article is based on the recruitment information provided for this vacancy. Candidates should independently verify the current status, eligibility, employment terms, and application details with the recruiting organization before sharing personal information or accepting an offer.
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