Job Description:

Role:                Manager Regulatory Affairs

Reports to:      Director

Experience:     7+ years experience in Regulatory Affair (Medical Device)

Location:         Navi-Mumbai

Education:       MSc-Microbiology, Biotechnology, Biochemistry, Biomedical or Life Sciences.

Responsibilities for this profile includes (but not limited) to:

· To head a regulatory team for 3 people

· Preparation and submission of documents for timely approvals.

· Maintaining product information as per requirements of country specific notified/ certifying

body

· Responsible for maintaining compliance ISO 13485:2016, MDSAP, INMETRO certification

· Liaise with other functions and participate as a member of a cross-functional team and

providing regulatory support.

Desired Skills:

· Applicants must be a first class Post Graduate in Microbiology, Biochemistry, Bio Technology,

Bio Medical or Life Sciences with good written and oral English

· Understanding of various ISO standards such as ISO 9001, 10993, 14971, IEC 60601 etc

would be added advantage