Job Title: Medical Device Complaint Handling Specialist
Summary:
Are you a detail-oriented Biomedical, Pharma, or Biotechnology graduate residing in Hyderabad with a passion for patient safety? We are seeking a motivated and experienced Medical Device Complaint Handling Specialist to join our growing team. In this role, you will be responsible for managing and processing customer complaints related to our medical devices, ensuring compliance with global regulatory standards, and contributing to the continuous improvement of our product safety and quality. If you have a strong analytical mindset, excellent documentation skills, and a desire to make a difference in the healthcare industry, we encourage you to apply.
About Us:
[Insert a brief description of your company and its mission/values here. This could include the type of medical devices you manufacture, your commitment to quality, and your focus on patient well-being.]
Job Description:
As a Medical Device Complaint Handling Specialist, you will play a crucial role in our post-market surveillance efforts, ensuring the safety and effectiveness of our medical devices. You will be responsible for investigating and documenting customer complaints, identifying potential safety issues, and escalating concerns to the appropriate teams for further investigation and resolution.
Key Responsibilities:
- Monitor and manage Drug/Medical Device Surveillance Programs.
- Review, assess, and process customer complaints in accordance with global regulatory standards, including FDA, EU MDR, and ISO 13485.
- Prepare and submit Medical Device Reports (MDRs) and Adverse Drug Experience (ADE) reports to regulatory agencies.
- Maintain complete and accurate documentation of all complaint files, ensuring compliance with internal procedures and regulatory requirements.
- Work cross-functionally with Quality Assurance (QA), Regulatory Affairs (RA), Engineering, and Field Teams to investigate and resolve complaints.
- Support risk evaluation activities, contributing to the identification and mitigation of potential product safety hazards.
- Provide input to Corrective and Preventive Action (CAPA) processes based on complaint trends and analysis.
- Assist with internal and external audits related to complaint handling processes.
- Conduct trend analysis of complaint data to identify potential areas for improvement in product design, manufacturing, or labeling.
- Communicate effectively with customers, healthcare professionals, and internal stakeholders regarding complaint investigations and resolutions.
Required Qualifications:
- Bachelor’s or Master’s degree in Pharmacy (preferred).
- OR Engineering degree in Biomedical or Biotechnology.
- 1-4 years of experience in Medical Device or Pharma complaint handling.
- Strong understanding of medical device regulations, including FDA 21 CFR Part 820, EU MDR, and ISO 13485.
- Experience with regulatory reporting tools and safety databases.
- Proven ability to analyze complex data and identify trends.
- Excellent documentation and communication skills.
- Strong problem-solving and critical thinking skills.
- Ability to work independently and as part of a team.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Must be located in Hyderabad, Telangana.
Job Benefits:
- Opportunity to work in a fast-growing and dynamic Medical Device Safety environment.
- Exposure to global regulatory frameworks and best practices.
- Career growth opportunities in Quality, Regulatory Affairs, Post-Market Surveillance (PMS), or Risk Management.
- Work location in Hyderabad’s prime corporate district.
- Professional development and training opportunities in patient safety systems and regulatory compliance.
- [Add other relevant benefits such as health insurance, paid time off, etc.]
Location:
Nanakramguda Financial District, Hyderabad, Telangana
How to Apply:
If you meet the qualifications and are interested in this exciting opportunity, please submit your resume to [Email Address]. Please include “Medical Device Complaint Handling Specialist Application” in the subject line.
Note: Only candidates located in Hyderabad will be considered.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.