Assistant Manager (Compliance & Regulatory Affairs)

17.00 to 22.00 Years Delhi 21 Mar, 2019

Job Location	Delhi
Education	Not Mentioned
Salary	Not Disclosed
Industry	Recruitment Services
Functional Area	ite Engineering / Project Management
EmploymentType	Full-time

Job Description

Salary: 3 Lac - 3 Lac

To study and understand the various procedures of Medical Device Approval,
To apply for medical device (Biologics) approval with FDA and EU,
He/She should be in a position to address the requirements of FDA and EU, MHRA, CBER, EMEA norms,
To continuously get involved in secondary research for Medical device approval,
Interact with regulatory bodies when ever required,
To carry out the various day to day operation and assist the Manager- Compliance and Regulatory Affairs to prepare documentations and technical files, Maintenance of the records,
Ability to learn new techniques, trouble shoot experiments, design experiments and execute them within tight timelines is a must,
Highly motivated to work in a team environment and enthusiastic to train in cross-functional areas

Desired Candidate Profile

Proper knowledge on biopharmaceuticals, medical devices and its classification
Basic understanding of physico-chemical testing, biological testing for full characterization, different biocompatibility test, Clinical comparability pathway, develop investigational medical product drossier, Acquaintance with FDAs Center for Biologics Evaluation and Research
Well versed with Directive 98/79/EC, Investigational New Drug or Device Exemption , Regulations regarding changes to an approved new drug application, biologics license application, or medical device premarket approval application, Regulatory Submissions in Electronic Format for Biologic Products, European Medicines Agency is mandatory
Experience and Sound knowledge of General requirements for in vitro diagnostic medical devices for self-testing, Clinical laboratory testing, Performance evaluation of in vitro diagnostic medical devices.
Excellent record keeping and computer skills especially well-versed with Microsoft office

Keyskills :
design management customer service

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Assistant Manager (Compliance & Regulatory Affairs)

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