regulatory affairs - devices in bengaluru / bangalore

posted
contact
randstad india
position type
permanent
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posted
location
bengaluru / bangalore
function
Pharma, healthcare & lifesciences
position type
permanent
experience
8
reference number
65066
contact
randstad india

job description

regulatory affairs - devices in bengaluru / bangalore

Below are the required skills.

·Master of Science (life sciences/technology) and/or PhD with typically some relevant working experience or Bachelor (life Sciences/technology) with relevant experience or equivalent knowledge through relevant practical experience.

·Above 6 years of experience in pharmaceutical industry in Regulatory Affairs Medical Device expertise (Class I and II, Combination products), Medical Devices Design & Development, Risk Management, Clinical Evaluation with a strong understanding of Medical Device Regulations and Change Management.

·Experience in preparing and maintenance of Medical Device Technical Files.

·Knowledge on CTD requirements for Combination Products/Devices with knowledge on ISO13485, MDSAP Requirements, 510(K), CE marking process for medical devices

·Experience in handling LCM of Medical Devices in European Union, United States, Japan and China.

·Possess a good communication skills including communication and presentation of ambiguous and complex data

·Communicating with Notified Bodies/ HAs with technical/scientific insight and professional authority. Competence in decision making, as well as flexibility and excellent cooperation in an international environment

·Highly proactive and able to take initiatives

skills

Regulatory affairs, medical devices, Clinical Trials Documentation, Clinical Trials Design

qualification

MS/M.Sc(Science)