Sign In
 [New User? Sign Up]
Mobile Version

Assistant Manager (Compliance & Regulatory Affairs)

Job Code:
  • Biotechnology & Science
Applying for this job will take you to an external site
  • Shortlist
  • Email Friend
  • Print

Job Details

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 areasDesired Candidate ProfileProper knowledge on biopharmaceuticals, medical devices and its classificationBasic understanding of physico-chemical testing, biological testing for full characterization, different biocompatibility test, Clinical comparability pathway, develop investigational medical product drossier, Acquaintance with FDA\\\'s Center for Biologics Evaluation and ResearchWell 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 mandatoryExperience 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
Additional Degree: B.Pharm. (Pharmacy)

Experience: 3-6


Medical Superintendent/Director | Ophthalmology | Regulatory Affairs
Applying for this job will take you to an external site


© Copyright 2015 Al Nisr Publishing LLC - powered by Gulf News