Job Description

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