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| Job Location | Surat |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | Quality (QA-QC) |
| EmploymentType | Full-time |
Be responsible for establishing in approved documents, maintain and continuously improve Quality System processes required by international, regional and national regulatory authorities and standards (e.g. MDD 93/42/EEC, ISO13485:2016, ISO 9001, ISO 60601, ISO 14971 etc), Performs New Product Development (NPD) gate audits to ensure project deliverables adhere to governing processes, Review changes to existing products and SOPs to define the requirements for regulatory submissions.Audit Knowledge is a must.EU MDR & Indian MDR knowledge is a must.Product Development QA RA. Provide quality and regulatory affairs input for the product development team and handle all QA & RA responsibilities through product development, design change and post market surveillance process.As part of core team, work with engineering team to ensure. Provide engineering and manufacturing with the relevant quality and regulatory affairs requirements that are part of Product Design Inputs for further product development. Product and Process Validation the establishment of product & process validation plans the appropriate execution and documentation of validation activities the review and approval of relevant documentation. Provide engineering and manufacturing with the relevant quality and regulatory affairs requirements that are part of product and process validation requirements Establish and analyse key performance indicators to evaluate and continuously improve the QMS Manage audits (internal and external) Requirements. Highly practical, hands on approach to quality system implementation, writing procedures, doing gap analysis with standards. Quality Engineering and Regulatory experience Excellent organizational and communication skills (including fluency in written and verbal English). Prior experience highly desired.Understating the regulatory framework and providing regulatory pathway for Device products. Understating of formats required for filling applications to CDSCO and preparation of the same. Knowledge of about Preparation of Dossier. Knowledge of addressing regulatory deficiencies. Exposure to regulatory audits. Review of DMF
Keyskills :
gapanalysis sow iso9001 iso14971 newproductdevelopment keyperformanceindicators qualitysystem qualitysystemimplementation postmarketsurveillance productdevelopment productdesign systemimplementation qa qualityengineering processvalidation