The medical devices industry in India is witnessing rapid expansion, creating exciting career opportunities for pharmacy graduates specialising in regulatory affairs. If you have experience in medical device regulations and are looking for your next career move, Blueneem Medical Devices Pvt. Ltd. has announced a new opening for the position of Regulatory Affairs Executive.

This opportunity is ideal for professionals with 1–2 years of experience in medical device regulatory affairs who possess an M.Pharm qualification and have knowledge of CDSCO registrations, ISO 13485, Clinical Evaluation Reports (CER), regulatory documentation, and post-approval changes.

If you’re passionate about ensuring regulatory compliance and contributing to the healthcare industry, this could be the perfect role for you.

📌 Blueneem Medical Devices Recruitment 2026 Overview

Particular	Details
Company	Blueneem Medical Devices Pvt. Ltd.
Position	Regulatory Affairs Executive
Qualification	M.Pharm
Experience	1–2 Years
Industry	Medical Devices
Department	Regulatory Affairs
Job Type	Full-Time
Job Location	As per company requirement
Salary	Best in Industry
Application Mode	Email

🏢 About Blueneem Medical Devices Pvt. Ltd.

Blueneem Medical Devices Pvt. Ltd. is an emerging medical devices company focused on delivering quality healthcare products while maintaining compliance with national and international regulatory standards.

The company emphasizes innovation, quality management, and regulatory excellence to ensure that its medical devices meet safety and performance requirements. Regulatory Affairs professionals at Blueneem play a vital role in obtaining approvals, maintaining registrations, and ensuring compliance with evolving medical device regulations.

Working with Blueneem offers professionals exposure to regulatory documentation, product registrations, quality management systems, and international regulatory frameworks.

🎓 Educational Qualification

Candidates should possess:

M.Pharm

💼 Experience Required

Applicants should have:

1–2 years of experience
Experience in the Medical Devices industry
Hands-on knowledge of regulatory affairs activities

📋 Job Role

The selected candidate will work as a Regulatory Affairs Executive, responsible for preparing regulatory dossiers, coordinating registrations, maintaining regulatory documentation, ensuring compliance with CDSCO requirements, and supporting medical device approvals.

✅ Key Responsibilities

The Regulatory Affairs Executive will be responsible for:

Preparing regulatory documentation for CDSCO registration.
Maintaining Device Master Files (DMF).
Preparing Plant Master Files (PMF).
Developing Essential Principles Safety and Performance (EPSP) documentation.
Coordinating product registrations.
Managing regulatory submissions.
Tracking approval timelines.
Handling registration renewals.
Responding to CDSCO queries.
Resolving regulatory issues.
Identifying Indian regulatory requirements.
Supporting international regulatory compliance.
Obtaining Free Sale Certificates (FSC).
Managing Market Standing Certificates.
Preparing Minor PAC dossiers.
Preparing Major PAC dossiers.
Maintaining Clinical Evaluation Reports (CER).
Ensuring compliance with Indian medical device regulations.
Coordinating with Quality Assurance teams.
Working with Manufacturing departments.
Collaborating with R&D teams.
Supporting cross-functional regulatory submissions.
Maintaining ISO 13485 documentation.
Ensuring Quality Management System compliance.

📚 Skills Required

Candidates should have knowledge of:

CDSCO Medical Device Regulations
Medical Device Rules (MDR)
Device Master File (DMF)
Plant Master File (PMF)
Essential Principles Safety & Performance (EPSP)
Clinical Evaluation Reports (CER)
Regulatory Submissions
Product Registration
Post Approval Changes (PAC)
ISO 13485
Quality Management Systems
Regulatory Documentation
Technical File Preparation
Risk Management
Medical Device Compliance
Documentation Control

🌟 Why Join Blueneem Medical Devices?

Working with Blueneem provides opportunities to:

Build a career in medical device regulatory affairs.
Gain exposure to CDSCO registrations.
Work with experienced regulatory professionals.
Learn international compliance procedures.
Enhance documentation expertise.
Improve regulatory strategy knowledge.
Gain practical exposure to ISO 13485.
Participate in product registration projects.
Build long-term career growth.

📖 Career Growth

Regulatory Affairs is among the fastest-growing domains in the medical devices industry.

After gaining experience in this role, professionals can progress to positions such as:

Senior Regulatory Affairs Executive
Regulatory Affairs Specialist
Regulatory Affairs Associate
Regulatory Affairs Manager
Compliance Manager
Quality Assurance Manager
Global Regulatory Affairs Specialist

Professionals with expertise in CDSCO regulations and international submissions are highly valued across medical device manufacturers, pharmaceutical companies, and healthcare organizations.

📄 Documents Required

Candidates should keep the following documents ready:

Updated Resume
M.Pharm Certificates
Experience Certificates
Latest Passport Size Photograph
Government ID Proof
Current CTC Details
Expected Salary Details
Notice Period Information

💡 Tips Before Applying

To improve your chances of selection:

Update your resume with regulatory affairs experience.
Highlight CDSCO registration knowledge.
Mention ISO 13485 exposure.
Include experience with DMF, PMF, and CER preparation.
Showcase regulatory submission projects.
Mention PAC documentation experience.
Keep supporting documents ready.

👩‍⚕️ Who Should Apply?

This opportunity is suitable for:

M.Pharm graduates
Regulatory Affairs Executives
Medical Device Regulatory Professionals
CDSCO Documentation Professionals
ISO 13485 Professionals
Medical Device Compliance Specialists

📈 Why Medical Device Regulatory Affairs is a Great Career

India’s medical device industry continues to grow due to increasing healthcare demand, manufacturing expansion, and stricter regulatory compliance.

Regulatory Affairs professionals ensure that medical devices meet safety, quality, and legal standards before reaching the market. Their expertise is essential for obtaining approvals, maintaining certifications, and supporting product lifecycle management.

As companies expand into international markets, professionals with experience in regulatory documentation, CDSCO approvals, ISO 13485, and clinical evaluation reports are expected to remain in high demand.

📧 Apply Now

Interested and eligible candidates can send their updated resume to:

📧 Email: careers@blueneem.com

Make sure your resume highlights your experience in regulatory affairs, medical device documentation, CDSCO registrations, and ISO 13485 compliance before applying.

Subject Line Suggestion: Application for Regulatory Affairs Executive – Blueneem Medical Devices

Apply as early as possible, as positions may close once suitable candidates are shortlisted.

Blueneem Medical Devices Recruitment 2026: Regulatory Affairs Executive | M.Pharm Candidates Apply Now