Regulatory Affairs

17 hours ago

Ambala HR IN QVC CERTIFICATION SERVICES PRIVATE LIMITED Full time

QVC CERTIFICATION SERVICES PVT LTD We are seeking a highly motivated and detail-oriented individual to join our Regulatory Affairs Department as a Regulatory Affairs Specialist The ideal candidate will have a background in Biotechnology Microbiology Nanotechnology Omics Bioinformatics Genetics or related domains along with a strong understanding of regulatory requirements for medical devices and IVDs JOB TITLE Regulatory Affairs Executive JOB CATEGORY Regulatory Department Group Regulatory Affairs Division - Medical Device IVD Location Ambala Travel required Occasional Will train applicant Yes Position type Full Time Employment FTE External posting URL www qvccert com APPLICATIONS ACCEPTED BY Fax or Email Subject line Regulatory Affairs Executive Application JOB DESCRIPTION Role and Responsibilities Conduct document review and gap analysis according to regulatory requirements including EU MDR 2017 745 IVDR 2017 746 and Indian MDR 2017 Review standard-specific and process-specific documents for compliance Analyze and identify gaps in validation processes Prepare PowerPoint presentations for training sessions based on industry requirements The Profile will be upgraded based on the performance Qualifications and Education Requirements Graduate or postgraduate degree in Biotechnology Microbiology Nanotechnology Omics Bioinformatics Genetics or related fields Proficiency in Microsoft PowerPoint Word and Excel Knowledge of sterilization methods material compatibility laboratory principles quality principles and QMS Quality Management System Familiarity with regulatory standards such as ISO 13485 ISO 14971 ISO 20416 and ISO 9001 Awareness of regulatory rules and regulations including the Medical Device Rules and Regulations for both the EU and India Preferred Skills Excellent attention to detail and organizational skills Strong analytical and problem-solving abilities Effective communication skills both written and verbal Ability to work independently and as part of a team Flexibility to adapt to changing priorities and deadlines Job Type Full-time Pay 50 000 00 - 70 000 00 per month Experience total work 1 year Preferred Work Location In person

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