GRK Medical Devices Private Limited has announced a hiring opportunity for the role of Regulatory Affairs Executive at its facility in Hyderabad, Telangana. This opportunity is ideal for freshers and early-career professionals (0โ2 years experience) with backgrounds in Pharmacy, Biomedical Engineering, or Engineering disciplines who want to build a career in medical devices regulatory affairs.
Regulatory Affairs professionals play a critical role in ensuring that medical devices comply with international quality standards and regulatory guidelines, including ISO standards and global regulatory frameworks such as EU MDR, US FDA, and CE Marking.
If you have completed an internship in a medical device company or have knowledge of regulatory compliance, this role could be an excellent starting point in the medical device regulatory affairs career path.
Job Details
| Field | Details |
|---|---|
| Position | Regulatory Affairs Executive |
| Company | GRK Medical Devices Private Limited |
| Job Location | ALEAP Industrial Estate, Pragathi Nagar, Hyderabad |
| Experience | 0 โ 2 Years |
| Qualification | B.Tech / M.Tech / B.Pharm / M.Pharm / Biomedical Engineering |
| Industry | Medical Devices |
| Employment Type | Full-Time |
Key Responsibilities
The Regulatory Affairs Executive will support compliance and documentation activities for medical device regulatory submissions and quality systems.
Responsibilities include:
- Assist in preparing regulatory documentation and technical files
- Ensure compliance with medical device regulatory standards
- Support regulatory submissions and approvals
- Maintain regulatory documentation according to ISO 13485 quality management systems
- Coordinate with internal teams for regulatory compliance
- Support regulatory activities related to product registration and certification
- Assist in regulatory audits and documentation reviews
- Stay updated with global medical device regulations
Required Qualifications
Candidates applying for the Regulatory Affairs Executive job in Hyderabad should meet the following criteria:
Educational Qualification
- B.Tech / M.Tech
- B.Pharm / M.Pharm
- Biomedical Engineering
Experience
- Fresher or 0โ2 years of experience
Technical Knowledge
Candidates should have knowledge of:
- ISO 13485 โ Medical Devices Quality Management System
- ISO 14971 โ Risk Management for Medical Devices
- ISO 11135 โ Sterilization of Medical Devices
- ISO 10993 โ Biocompatibility Evaluation of Medical Devices
Preferred Knowledge
- EU Medical Device Regulation (MDR)
- US FDA regulatory pathways
- CE Marking requirements
- Medical device documentation and regulatory processes
Candidates with internship experience in medical device companies will have an advantage.
Skills Required
Successful candidates for the medical devices regulatory affairs role should possess:
- Regulatory documentation skills
- Knowledge of medical device standards
- Understanding of regulatory submissions
- Attention to detail and compliance awareness
- Ability to work with cross-functional teams
Benefits of This Role
Working as a Regulatory Affairs Executive at GRK Medical Devices offers several career advantages:
- Entry into the medical device regulatory affairs industry
- Hands-on exposure to global regulatory frameworks
- Experience with ISO standards and compliance systems
- Opportunity to work with regulatory documentation and submissions
- Strong foundation for career growth in Regulatory Affairs, Quality Assurance, and Compliance
Job Location
The position is based at:
ALEAP Industrial Estate
Pragathi Nagar
Hyderabad, Telangana, India
How to Apply
Interested candidates who meet the eligibility criteria can directly send their updated resume to the HR team.
Email: hradmin@majikmed.com
Applicants are encouraged to mention โApplication for Regulatory Affairs Executive โ GRK Medical Devicesโ in the subject line.