Regulatory Affairs Executive - Medical Devices

Why This Role Matters
Regulatory Affairs professionals play a crucial role in ensuring that medical devices meet international safety, quality, and regulatory standards before reaching the market. Their work ensures that healthcare products comply with global regulatory frameworks such as ISO standards, CE marking requirements, and international medical device regulations. This role supports the safe development and distribution of medical devices while helping companies navigate complex regulatory environments and maintain compliance with industry standards.

Job Description
The Regulatory Affairs Executive position with GRK Medical Devices Private Limited is an entry-level opportunity for freshers and early-career professionals interested in building a career in the medical devices regulatory affairs field. The role is based in Hyderabad and involves supporting regulatory documentation, compliance activities, and product registration processes for medical devices. The executive will work closely with cross-functional teams to ensure regulatory standards are met and assist with preparing documentation required for regulatory approvals. This position provides valuable exposure to global regulatory frameworks and quality management systems used in the medical device industry.

Key Features of the Role:
• Entry-level opportunity in the medical devices regulatory affairs field
• Suitable for freshers and professionals with up to 2 years of experience
• Exposure to international regulatory frameworks and ISO standards
• Opportunity to work on regulatory documentation and compliance activities
• Hands-on experience with quality management systems and regulatory submissions

Responsibilities
• Assist in preparing regulatory documentation and technical files for medical device submissions
• Ensure compliance with applicable medical device regulatory standards
• Support regulatory submissions and product approval processes
• Maintain regulatory documentation according to ISO 13485 quality management system requirements
• Coordinate with internal departments to support regulatory compliance activities
• Assist in product registration and certification processes
• Support internal and external regulatory audits and documentation reviews
• Monitor updates in global medical device regulations and ensure internal compliance

Required Qualifications

Educational Requirements:
• Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm)
• Biomedical Engineering

Experience and Skills:
• Fresher or candidates with 0–2 years of relevant experience
• Internship experience in a medical device company is preferred
• Knowledge of regulatory documentation and compliance processes
• Attention to detail and strong documentation skills
• Ability to collaborate with cross-functional teams
• Good analytical and organizational abilities

Technical Knowledge:
Candidates should have familiarity with the following standards:
• ISO 13485 – Quality Management System for Medical Devices
• ISO 14971 – Risk Management for Medical Devices
• ISO 11135 – Sterilization of Medical Devices
• ISO 10993 – Biocompatibility Evaluation of Medical Devices

Preferred knowledge includes:
• EU Medical Device Regulation (MDR)
• US FDA regulatory pathways
• CE Marking requirements
• Medical device regulatory documentation processes

Salary Insights
Salary details are not specified in the job announcement. Compensation typically depends on candidate qualifications, experience, and company policies.

Company Overview
GRK Medical Devices Private Limited is a medical device organization involved in the development, manufacturing, and regulatory compliance of healthcare devices. The company focuses on maintaining international quality standards and regulatory compliance to ensure safe and effective medical products.

FAQs
Where is the job located?
• ALEAP Industrial Estate, Pragathi Nagar, Hyderabad, Telangana

What experience is required?
• Freshers or candidates with 0–2 years of experience can apply

What qualifications are required?
• B.Pharm, M.Pharm, or Biomedical Engineering

What industry is this role in?
• Medical Devices and Regulatory Affairs

Application Tips
• Highlight coursework or projects related to regulatory affairs or quality systems
• Mention internship experience in medical device or pharmaceutical companies
• Demonstrate knowledge of ISO standards and regulatory compliance processes
• Emphasize attention to detail and documentation skills
• Include any exposure to regulatory submissions, CE marking, or FDA regulations if applicable