QA/RA(Quality Assurance and Regulatory affairs)Specialist

QA/RA(Quality Assurance and Regulatory affairs)Specialist

Posted by Upshot Engineering Llp

Chennai

Posted: imported by Jeevika

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The candidate will be responsible for preparing Technical Documentation/Technical Files and ensuring compliance with global regulations and standards including EU MDR, ISO 13485, ISO 14971, FDA 21 CFR, and ISO 10993.Key ResponsibilitiesTechnical Documentation & Regulatory SubmissionsPrepare, compile, review, and maintain Technical Documentation/Technical Files for medical devices. Develop and review Device Description, Intended Use, Labeling, and GSPR documentation. Support regulatory submissions for EU MDR, CE Marking, FDA 510(k), and other international markets. Coordinate with cross-functional teams for regulatory submission requirements. Risk ManagementDevelop and maintain Risk Management Files as per ISO 14971. Conduct hazard analysis, risk evaluation, risk control, and benefit-risk assessments. Ensure traceability between risks, product requirements, verification activities, and mitigations. Clinical Evaluation & Post-Market ActivitiesPrepare and update Clinical Evaluation Reports (CER) in accordance with EU MDR. Support Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) activities. Review post-market data, complaints, and vigilance reports for regulatory compliance. Verification & ValidationReview Verification and Validation (V&V) reports for regulatory and design compliance. Ensure traceability between product requirements and validation evidence. Support software validation documentation, wherever applicable. Quality & ComplianceEnsure compliance with ISO 13485 Quality Management System requirements. Participate in internal and external audits. Monitor and evaluate changes in global medical device regulations and applicable standards. Maintain accurate regulatory records and ensure effective document control. Required QualificationsBachelors or Masters degree in Biomedical Engineering, Biotechnology, Life Sciences, Pharmacy, Regulatory Affairs, or a related field. 4+ years of experience in Medical Device Regulatory Affairs. Hands-on experience in preparing and maintaining Technical Files/Technical Documentation. Strong knowledge of EU MDR 2017/745, ISO 13485, ISO 14971, and ISO 10993. Experience with CER, PMS, PMCF, and Risk Management documentation. Strong technical writing, documentation, and document control skills.Role: Research & Development - Other,Industry Type: Biotechnology,Department: Research & Development,Employment Type: Full Time, PermanentRole Category: Research & Development - OtherEducationUG: B.Tech / B.E. in Bio-Chemistry/Bio-Technology, Biomedical Engineering, B.Pharma in Any SpecializationKey SkillsSkills highlighted with ‘‘ are preferred keyskillsMedical DevicesTechnical DocumentationBiotechnologyISO 14971ISO 13485PharmaceuticsEU MDR 2017/745ISO 10993Risk ManagementMedical EquipmentRegulatory SubmissionsRegulatory AffairsPharmacyBiomedicalAbout companyUpshot Engineering LlpCompany InfoAddress:ChennaiBeware of imposters! Naukri.com does not promise a job or an interview in exchange of money. 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