Complaints Handler

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com

What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it?

We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers.

We are a rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you.

If this excites you, then apply below

Performing the support activities for Customer feedback, Complaints Handling, Medical Device Reporting (MDR) and Recall Management services.

Initiate complaint in process and applicable tool.

Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint

Ensure complaints are classified correctly and that all supporting data are adequately documented and attached to the complaint file.

Ensure the efficient receipt, documentation, and registration of customer complaints via various channels (phone, email, website).

Categorize and prioritize complaints based on severity and potential impact on patient safety and product quality.

Collaborate with cross-functional departments, including Quality Assurance, Regulatory Affairs, and Product Development, to gather necessary information for investigation.

Maintain comprehensive and meticulously organized records of all complaint-related activities, including investigations, findings, and resolutions.

Ensure records are compliant with regulatory standards and are readily accessible for audit and review purposes.

Prepare and communicate regular reports on complaint trends, analysis, and resolution status to senior management.

Partners cross functionally with Safety, Risk Management and/or the manufacturer when a technical investigation is required.

Maintain open and transparent communication with complainants, providing updates on complaint progress and resolution timelines.

Stay abreast of evolving medical device regulations and standards, ensuring the complaints handling process remains compliant.

Bachelor's degree in a relevant field (e.g., Life Sciences, Engineering, Quality Management); Master's degree preferred.

5 years of experience in medical device quality and regulatory, with 3+ years in complaints handling in medical devices

Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971.

Experience in trackwise digital and/or SAP to handle complaints.

Excellent problem-solving and analytical skills.

Product Knowledge is preferred.

Exceptional interpersonal and communication skills.

Proficiency in complaint tracking software and Microsoft Office Suite.

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.