Job Opportunity: Regulatory Affairs Executive at GRK Medical Devices Private Limited

Summary

GRK Medical Devices Private Limited is inviting applications for the position of Regulatory Affairs Executive at our Hyderabad facility. This is an exceptional opportunity for fresh graduates or early-career professionals (0–2 years of experience) in Pharmacy, Biomedical Engineering, or related Engineering fields to launch their careers in the specialized domain of medical device regulatory compliance. Join us to play a pivotal role in ensuring that our life-saving technologies meet the highest international quality and safety standards.

About the Role

At GRK Medical Devices, we are committed to innovation and excellence in the healthcare sector. As a Regulatory Affairs Executive, you will act as a bridge between our product development teams and global regulatory authorities. You will be responsible for ensuring that our products navigate the complex landscapes of international quality standards, including ISO protocols and global frameworks like the EU MDR, US FDA, and CE Marking. This role is designed for detail-oriented individuals who are eager to master the intricacies of regulatory submissions, quality management systems, and technical documentation.

Job Details

• Position: Regulatory Affairs Executive
• Company: GRK Medical Devices Private Limited
• Location: ALEAP Industrial Estate, Pragathi Nagar, Hyderabad, Telangana
• Experience: Fresher to 2 Years
• Qualification: B.Tech / M.Tech / B.Pharm / M.Pharm / Biomedical Engineering
• Employment Type: Full-Time

Key Responsibilities

The Regulatory Affairs Executive will be an integral part of our quality and compliance team. Your daily responsibilities will include, but are not limited to:

• Documentation Excellence: Assisting in the preparation, compilation, and review of regulatory documentation and technical files required for product submissions.
• Compliance Oversight: Ensuring that all internal processes and products strictly adhere to established medical device regulatory standards.
• Regulatory Submissions: Supporting the team in the end-to-end process of product registration, certification, and regulatory approvals.
• Quality Management: Maintaining regulatory documentation in alignment with ISO 13485 (Quality Management Systems) requirements.
• Cross-Functional Collaboration: Coordinating with internal departments—including R&D, Quality Assurance, and Engineering—to streamline compliance efforts.
• Audits & Reviews: Providing essential support during regulatory audits and performing thorough documentation reviews to identify and mitigate compliance gaps.
• Regulatory Intelligence: Staying current with evolving global medical device regulations to ensure our strategies remain proactive and effective.

Required Qualifications & Technical Knowledge

We are looking for candidates who possess a solid academic foundation and a keen interest in regulatory science.

• Educational Background: A degree in B.Tech/M.Tech, B.Pharm/M.Pharm, or Biomedical Engineering.
• Experience: Open to fresh graduates or professionals with up to 2 years of experience in the medical device industry. Prior internship experience in a regulatory or quality department is considered a significant advantage.
• Core Technical Knowledge: Proficiency or strong academic understanding of:
  • ISO 13485: Medical Devices Quality Management System.
  • ISO 14971: Risk Management for Medical Devices.
  • ISO 11135: Sterilization processes.
  • ISO 10993: Biocompatibility Evaluation.
• Preferred Knowledge: Familiarity with EU Medical Device Regulation (MDR), US FDA regulatory pathways, and CE Marking requirements will be highly valued.

Skills Required

• Meticulous Attention to Detail: Ability to review complex documents with precision.
• Compliance Mindset: Strong understanding of regulatory processes and the importance of standard operating procedures.
• Technical Writing: Capability to draft clear, accurate, and concise regulatory documents.
• Teamwork: A collaborative spirit to work effectively across different functional teams within the company.

Why Join GRK Medical Devices?

This position provides a robust platform for professional growth. By joining us, you will:

• Gain direct exposure to global regulatory frameworks and international market requirements.
• Build a deep understanding of ISO standards, which are highly sought after in the healthcare manufacturing industry.
• Develop a strong foundation for a long-term, successful career in Regulatory Affairs, Quality Assurance, and Compliance.

How to Apply

If you are a motivated professional ready to contribute to the medical device landscape, we encourage you to apply.

Please send your updated resume to: [email protected]

Subject Line: Please ensure you mention “Application for Regulatory Affairs Executive – GRK Medical Devices” in the subject line of your email. We look forward to reviewing your application!