Complaint Handling Specialist – Medical Device Industry
Saraca Solutions is seeking a detail-oriented and experienced Complaint Handling Specialist to join our team within the medical device industry. In this role, you will be responsible for managing the end-to-end complaint handling process, ensuring compliance with global regulatory standards and contributing to the safety and quality of our products. If you have a background in Pharma or B.Tech, possess strong analytical and technical writing skills, and are passionate about patient safety, we encourage you to apply.
Job Summary:
The Complaint Handling Specialist will manage and process customer complaints related to medical devices, ensuring compliance with applicable regulations and internal procedures. This position involves investigating complaints, documenting findings, and collaborating with cross-functional teams to implement corrective and preventive actions. The ideal candidate will possess excellent communication, analytical, and technical writing skills.
Responsibilities:
- Manage the complete lifecycle of medical device complaints, from initial receipt to closure, in accordance with relevant medical device regulations (e.g., FDA, ISO).
- Prepare comprehensive and technically sound complaint summaries, investigation reports, and other required documentation.
- Conduct thorough investigations to identify the root cause of complaints, utilizing appropriate analytical techniques and problem-solving methodologies.
- Collaborate effectively with cross-functional teams, including engineering, manufacturing, quality assurance, and regulatory affairs, to facilitate investigations and implement corrective actions.
- Ensure accurate and timely documentation of all complaint-related activities in the complaint management system.
- Maintain a strong understanding of global complaint handling processes, regulatory requirements, and patient safety considerations.
- Contribute to the development and improvement of complaint handling procedures and processes.
- Monitor complaint trends and identify potential product or process improvements.
- Participate in internal and external audits related to complaint handling activities.
Requirements:
- Education: Bachelor’s degree in Pharmacy (B.Pharm), Master’s degree in Pharmacy (M.Pharm), or Bachelor of Technology (B.Tech).
- Experience: 1-5 years of experience in complaint management, technical documentation, quality assurance (QA), regulatory affairs (RA), or related functions within the medical device industry.
- Strong analytical and problem-solving skills with the ability to interpret technical data and draw conclusions.
- Excellent technical writing skills with the ability to create clear, concise, and accurate documentation.
- Effective communication and interpersonal skills to collaborate with cross-functional teams and external stakeholders.
- Familiarity with medical device complaint handling regulations (e.g., 21 CFR Part 820, ISO 13485) is highly preferred.
- Ability to work independently and manage multiple tasks simultaneously.
- Proficiency in using complaint management systems and other relevant software applications.
Benefits & Growth Opportunities:
- Be part of a leading and innovative company within the medical device sector.
- Opportunity to develop a specialized career in complaint management and device safety, contributing directly to product quality and patient well-being.
- Gain exposure to global regulatory processes and contribute to ensuring compliance in a regulated environment.
- Receive a competitive salary and benefits package.
- Enjoy a strong professional development environment with opportunities for training and advancement.
How to Apply:
If you meet the qualifications and are interested in this exciting opportunity, please submit your resume to [email protected]. Please use the following subject line: Complaint Handling – Immediate to 30 Days NP. We look forward to hearing from you.