Hariharan Palani
Remediation Engineer | Regulatory Specialist | Technical Documentation | Regulatory Compliance Specialist | ISO 13485 | Design Control | EU MDR | US FDA | ISO 14971 | MDR
- Role
- Regulatory Compliance Specialist at Cyient
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Hariharan Palani
With over 6 years of extensive experience in the medical device industry, I specialize in…
Experience
Regulatory Compliance Specialist
Sep 2022 — Present · Hyderabad, IN
I am a dedicated regulatory and quality systems professional with hands-on experience in Design History File (DHF) compilation and Technical File documentation aligned with 21 CFR Part 820 (QSR) and EU-MDR. My expertise spans ISO 13485, CGMP, and ISO 14971, with a strong focus on ensuring medical device compliance across U.S. and European markets.Key areas of expertise include: Design & Risk Management: Skilled in developing and remediating risk management files, including DFMEA and PFMEA, and driving compliance through design control reviews with cross-functional teams. Regulatory Documentation & Strategy: Act as a Subject Matter Expert (SME) for Class I medical devices, supporting regulatory strategies that align with business goals and ensuring documentation meets all relevant standards. Product Compliance & Environmental Regulations: Experienced in gathering compliance data for global regulatory programs such as RoHS, REACH, SCIP, TSCA, PFAS, POPs, and California Proposition 65. Quality Systems & Process Improvement: Lead initiatives involving CAPA, Non-conformities (NC), and Change Requests (CR) while upholding high standards for process compliance and documentation accuracy. Gap Assessments & Audits: Perform gap analyses, risk control reviews, and defect analysis reporting to continuously improve product and process compliance. Data Integrity & Visualization: Conduct data quality reviews across product lifecycle workflows, ensuring data integrity, and provide insights through Power BI dashboards and data visualizations.
Education
Government higher secondary school
Matriculation, Maths-Biology
2013 — 2015
Amritha higher secondary school
Secondary, Maths-Science
2011 — 2013
College of Engineering, Guindy
Bachelor's degree, Biomedical/Medical Engineering
2015 — 2019
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