Post: Officer / Executive - Regulatory Affairs
Job Description
- Responsible to face ISO and CE Audits arranged by company.
- Responsible to keep record of regulatory and statutory guidelines and applicable harmonized standards for medical device.
- Responsible to guide in preparation / update of Quality Management System Documents Responsible to prepare / review / update Design Master File, Technical Master File
- Responsible to prepare / review / update Technical documentation for the international registration of products.
- Responsible to prepare / review / update to get clinical trial approval from Drug Controller General India.
-Responsible to keep record of regulatory and statutory guidelines and applicable harmonized standards for medical device.
Job Description
- Responsible to face ISO and CE Audits arranged by company.
- Responsible to keep record of regulatory and statutory guidelines and applicable harmonized standards for medical device.
- Responsible to guide in preparation / update of Quality Management System Documents Responsible to prepare / review / update Design Master File, Technical Master File
- Responsible to prepare / review / update Technical documentation for the international registration of products.
- Responsible to prepare / review / update to get clinical trial approval from Drug Controller General India.
-Responsible to keep record of regulatory and statutory guidelines and applicable harmonized standards for medical device.
Candidate Profile
Experience required upto 1 year and fresher can also apply.
Experience required upto 1 year and fresher can also apply.
Additional Information:
Education: B.Pharm, M.Pharm
Experience: 0-1
Location: Surat- Gujarat
Industry: Pharma/Biotech
Last Date: 5th Sept, 2016
Education: B.Pharm, M.Pharm
Experience: 0-1
Location: Surat- Gujarat
Industry: Pharma/Biotech
Last Date: 5th Sept, 2016
Please mail your cv at hr@espl.net.in
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