Are you a detail-oriented professional with a passion for ensuring the safety and efficacy of medical devices? Amgen, a global leader in biotechnology, is seeking a Medical Device Complaint Specialist with 5 years of experience to join our dynamic team in Hyderabad. If you have a strong background in handling medical device complaints and are ready to take on a rewarding challenge, this opportunity is for you!
Job Description: Medical Device Complaint Specialist
Location: Hyderabad (Hybrid Work Model)
Experience: 5+ years
Job ID: R-205446
Key Responsibilities:
- Investigate and resolve medical device complaints in compliance with regulatory standards.
- Ensure timely and accurate documentation of complaint handling processes.
- Collaborate with cross-functional teams to address quality and safety concerns.
- Analyze complaint data to identify trends and recommend corrective actions.
- Maintain compliance with FDA, ISO, and other regulatory requirements.
- Provide support during audits and inspections related to medical device complaints.
Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, or a related field.
- Minimum of 5 years of experience in handling medical device complaints.
- Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and other regulatory standards.
- Excellent analytical, problem-solving, and communication skills.
- Proficiency in using complaint management software and tools.
About Amgen
Amgen is a world-renowned biotechnology company dedicated to discovering, developing, and delivering innovative human therapeutics. Our mission is to serve patients by transforming the promise of science into breakthrough medicines. With a strong commitment to quality and safety, Amgen has been at the forefront of advancements in the medical device industry.
Joining Amgen means becoming part of a culture that values innovation, collaboration, and excellence. We offer a supportive work environment, opportunities for professional growth, and the chance to make a meaningful impact on patients’ lives worldwide.
How to Apply
If you’re ready to take the next step in your career and contribute to the safety and efficacy of medical devices, we want to hear from you!
📧 Email your resume to: averma20@amgen.com
📌 Subject Line: Application for Medical Device Complaint Specialist (R-205446)
Don’t miss this opportunity to join a global leader in biotechnology and make a difference in the medical device industry!
