Meril is hiring Assistant Manager

Location: Remote

Qualification: B.Pharm, M. Pharm, Ph.D. in Life sciences

Experience: Minimum 3 years of experience in medical device regulatory document preparation including Clinical Evaluation Report, Post-Market Surveillance Report, Post-Market Clinical Follow-up Plan/Report etc

Job Description

·Lead (writing and reviewing) the development and completion of regulatory documents for medical devices including but not limited to:

a.Clinical Evaluation Plan (CEP)/Report (CER)
b.Post-Market Surveillance (PMS) Plan/Report
c.Periodic Safety Update Report (PSUR)for Medical devices
d.Post-Market Clinical Follow-up (PMCF) Plans/Reports
e.Summary of Safety and Clinical Performance (SSCP) Report

·Conduct literature searches and clinical evidence mapping, manage the literature database, and prepare literature reviews
·Work in a cross functional team and draft the regulatory documents
·Facing internal and external regulatory audits
·Develop and maintain SOPs and writing tools, such as templates and style manuals
·A Bachelor degree with a minimum of 2 years of experience in scientific writing or an advanced degree with a minimum of 1 year experience in scientific writing
·Strong verbal, written, and interpersonal communication skills
·Knowledge in Medical Device regulatory process
·Knowledge in Medical Device regulations including MEDDEV Rev. 4, MDR
·Experience in conducting focused literature searches on PubMed, MedLine or other similar medical literature database

Requirements
Minimum 3 years of experience in medical device regulatory document preparation including Clinical Evaluation Report, Post-Market Surveillance Report, Post-Market Clinical Follow-up Plan/Report etc.

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