A world leader in the field of diagnostics for 50 years, bioMérieux is present in more than 150 countries through 42 subsidiaries and a large network of distributors. In 2014, revenues reached €1,698 million with 88% of sales outside of France.in vitro We look above all for people willing to make a commitment with us in an entrepreneurial project supported by a strong corporate culture. The pillars that support bioMérieux's teams are our pioneering spirit, our international vision, our roots, and our social commitment to improve public health worldwide.
Post : Senior Executive - Regulatory Affairs - 42990
Job Description
A strong Scientific and technological pioneering spirit drives bioMérieux development since its creation in 1963. We design innovative in vitro diagnostic solutions for our customers that initiate new forms of scientific partnerships to be at the forefront of the most advanced technologies. Our presence in more than 150 countries with 9,400 employees worldwide secures bioMérieux commitment to public health.
1. Must ensure that all our solutions are covered under valid DCI licenses at all times. When new products are introduced licenses shall be applied for and obtained according to timelines agreed for the launch.
2. Work closely with global stake-holders to request for and obtain relevant documentation, etc., in a timely manner.
3. Be technically conversant with our solutions so that validation procedures can be successfully driven and completed as per DCI rrequirements.
Candidate Profile :
Qualifications:- Post Graduate in any Engineering or Life Science field.
Experience:-
1. Atleast 5 years in regulatory affairs function in a medium sized company preferably in IVD handling regulatory requirements with the DCI office.
2. Must be completely familiar with all current procedures for application and obtaining medical device stock and sell license from the DCI.
3. Should have experience in NIB / other institution medical device validation process and be capable of actively particpating in such processes technically.
Additional Information:
Experience: 5 years
Qualification: M.Pharm
Location: Delhi
Industry Type: Pharma
Functional Area: Regulatory Affairs
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