Education: B.Pharmacy/M.Pharmacy
Experience: 1- 5 years
Salary: 2,00,000 - 3,00,000 P.A
No. of openings: 1
Job location: Pune
Job duties:
>Responsible for Interface with regulatory authorities (local as well as International) on regulatory and technical matters, as appropriate.
>Responsible for submission activities of Implants / instruments & Device regulatory approvals including the CE marking, FDA, US- FDA (510K), [premarket approvals (PMAs), Regulatory notifications, post-approval reports, annual reports, Export certificates, and free sale certificates]
>Responsible to Maintain the knowledge of current regulatory (Indian FDA & US FDA ) & other countries requirements and standards of common Technical Documents and Quality related matters
Required skills:
>Must have excellent interpersonal skills and communication skills, written and oral - in English.
>Good knowledge about cGMPs guidelines, ISO13485 / ISO 9001, 21 CFR Parts 820 and other applicable Local & Global regulatory standards.
>Must be able to multi-task and evaluate self/team priorities effectively, ability to handle conflict with confidence and integrity along with sound organizational skills.
Interested and eligible people send your updated resume to
biorad@bioradmedisys.com
Phone: +91-080-2648 0683 / 84
Experience: 1- 5 years
Salary: 2,00,000 - 3,00,000 P.A
No. of openings: 1
Job location: Pune
Job duties:
>Responsible for Interface with regulatory authorities (local as well as International) on regulatory and technical matters, as appropriate.
>Responsible for submission activities of Implants / instruments & Device regulatory approvals including the CE marking, FDA, US- FDA (510K), [premarket approvals (PMAs), Regulatory notifications, post-approval reports, annual reports, Export certificates, and free sale certificates]
>Responsible to Maintain the knowledge of current regulatory (Indian FDA & US FDA ) & other countries requirements and standards of common Technical Documents and Quality related matters
Required skills:
>Must have excellent interpersonal skills and communication skills, written and oral - in English.
>Good knowledge about cGMPs guidelines, ISO13485 / ISO 9001, 21 CFR Parts 820 and other applicable Local & Global regulatory standards.
>Must be able to multi-task and evaluate self/team priorities effectively, ability to handle conflict with confidence and integrity along with sound organizational skills.
Interested and eligible people send your updated resume to
biorad@bioradmedisys.com
Phone: +91-080-2648 0683 / 84
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