Sr. Executive

Key responsibilities Duties 1 Documents preparation and submission for Test license Manufacturing license import license loan license certificates as per IMDR-2017 2 Thorough Knowledge able to prepare documents pertaining to EU MDR FDA 510 K requirements for medical devices for Class IIb III implants 3 Documents preparation related to Clinical evaluation PMS PMCF Adverse event handling product recall Design validation requirements etc 4 Documents preparation according to other countries regulatory requirements for Export registration 5 Query handling submission and facing CDSCO audits ISO 13485 EU MDR audits 6 Meeting CDSCO officer to clarify technical queries and for follow up on submission 7 Customer complaint handling and timely closing 8 Coordination of post-market activities e g surveillance clinical evaluation customer feedback failure analysis 9 Active participant of Risk management activities of any new product development 10 Label review as per regulatory requirements 11 Assisting head of the department for overall QA RA related activities 12 Assisting head of the department for other documents preparations regulatory submissions Knowledge Experience Minimum 3 years working in the Medical Device manufacturing Industry is must 1 Working within an ISO 13485 Quality Management System under the Medical Devices Directive MDD Medical Devices Regulation MDR for product development and or manufacturing in the UK EU is essential 2 Knowledge of other regional quality regulatory obligations is desirable 3 Experience of sterile single-use devices including process validation is desirable 4 Good interpersonal and negotiation skills 5 Excellent attention to detail is essential 6 Knowledge of Good documentation practices 7 A strong team player who is motivated by the success of the business 8 A self-starter committed to making things happen Education A degree or higher degree in an Engineering Sciences