Assistant Manger (Regulatory Affairs)

Assistant Manger (Regulatory Affairs)

Posted by Pharmaceutical Company

Vadodara

Posted: imported by Jeevika

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Designation Assistant Manager (Regulatory Affairs) Qualifications Graduate or Post Graduate Department Regulatory Affairs Dept. Experience 03 to 07 Years Location Vadodara Job Profile Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy Timely compile materials for license renewals, updates and registrations Maintain regulatory files/databases and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners Review labeling and labels for compliance with regulatory requirements Review changes to existing products and SOPs to define the requirements for regulatory submissions Provide the regulatory reviews of customer complaints and define the regulatory report ability. Documents preparation for ISO13485, CE Certificate (As per EU MDR). Work on a technical master file. Work on CERs (clinical evaluation report) as per EU MDR. Have knowledge about QMS (quality management systems). Reporting to regulatory authorities. Conducting internal quality audits. Responsibilities for initiating & closing product recall Process. Have experience or knowledge of European CE (MDD & MDR). Have knowledge of USFDA Other activities instructed by Manager. Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.Role: Regulatory Affairs Compliance,Industry Type: Medical Devices & Equipment,Department: Legal & Regulatory,Employment Type: Full Time, PermanentRole Category: Corporate AffairsEducationUG: Any GraduatePG: Any PostgraduateKey Skillsregulatory submissionsquality managementregulatory documentationcompliancecustomer complaintsmanufacturingregulatory affairsauditstransportationAbout companySharma Orthopedic India Pvt Ltd operates in the medical devices and healthcare equipment industry, specializing in the design and manufacturing of orthopedic implants and surgical instruments. Their careers page highlights opportunities in engineering, production, quality assurance, and sales, reflecting a strong focus on advancing orthopedic care through precision technology. By combining innovation with international standards, the company provides reliable orthopedic solutions while offering professionals rewarding careers in medical device manufacturing, healthcare technology, and global distribution.Beware of imposters! Naukri.com does not promise a job or an interview in exchange of money. 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