hiring for Regulatory Affairs Specialist for Pune location.
Bachelors degree in a software, technical, or biomedical discipline
Minimum of 2-4 years of Experience in medical device regulated environment.
Experience with successful preparation and submission of 510(k) or international documents for registration and/or marketing of medical devices worldwide
Excellent working knowledge of medical device regulations, FDA law, MDR, other global laws and regulations
Experience in supporting international registrations (FDA) and clinical investigations (preference) Regulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs). (preference) Knowledge of the NMPA requirements. (preference) Excellent verbal and written communication skills
(English) Enthusiastic, self-motivated regulatory professional Good communicator and team player who can work in a flexible and goal-oriented environment
Structured way of working
Problem-solving and time management skills
Please apply via Referral link: https://lnkd.in/dk9XQS4t
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