Apply on Kit Job: kitjob.in/job/4mut23

HCLTech Walkin Medical/Lifescience Hiring for Chennai Location on 30th May

Join a team that values innovation, growth, and impactful work. Don't miss the chance to work with cutting-edge Project in SME and be a part of something transformative!

Apply: https://forms.office.com/r/hgh0R0bc0Z

?#DriveDate:30th May Saturday (9AM-2PM)

#ContactPerson: Katherine Sylvia

?#VenueLocation: Chennai/Hyderabad

HCLTech Elcot Sez,

Current Cafeteria 2nd Floor

602/3, 138, Medavakkam High Road,

Sholinganallur, Chennai-600119

Experience: 5-10 years

Job Location: Chennai , Hyderabad

Skill:

- Global Complaints handling with medical device quality standards (FDA 21 CFR Part 820 and ISO 13485).
- Post Market surveillance Investigating report writing

JD:

Key Responsibilities

Qualifications

- Clinical Background: Bachelor’s degree or higher in a clinical or life sciences field (e.g., Nursing, Biomedical Engineering, Medicine, or equivalent healthcare experience)
- Regulatory Knowledge: Hands-on experience with medical device quality standards (FDA 21 CFR Part 820 and ISO 13485).
- Analytical Capability: Proven experience with statistical trending methodologies, data analysis tools,



and technical scientific writing within a regulated environment.
- Post Market surveillance Investigating report writing

Experience in,

- Determining compliance dispositions for all identified trend signals, documenting technical rationales to justify whether escalation to a CAPA is required.
- Authoring comprehensive Global Complaint Trending Signal Reports, ensuring meticulous documentation of the investigation scope, data analysis, and final risk-based conclusions.
- Contributing to IPC reviews where applicable, mapping post-market field feedback to manufacturing operations and in-process controls to identify potential systemic source issues.
- Collaborate with cross-functional teams—including Quality Engineering, R&D;, and Medical Affairs—to conduct RCA on confirmed product trends.
- Maintain audit-ready documentation that aligns with global regulatory standards

Contact Person: Katherine Sylvia

Interested candidates can share their CV on below mail id [email protected] with Below details Current Company, Current CTC, Expected CTC, Notice Period, Location.

Apply on Kit Job: kitjob.in/job/4mut23

📌 HCLTech WalkIn Medical/Life science in Chennai on 30th May
🏢 HCLTech
📍 Chennai