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Haystack Analytics
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Assistant Manager Quality and Regulatory

Assistant Manager Quality and Regulatory

Haystack Analytics

4 - 7 years

3 - 7 Lacs

Mumbai Hyderabad

Posted:4 hours ago| Platform:

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Skills Required

regulatory auditing internal audit quality assurance pathway fup payments dbms sql emv jcl pos enscribe tal inspection tacl scobol documentation ddl quality check quality management medical devices cobol tandem enform

Work Mode

Work from Office

Job Type

Full Time

Job Description

What We Want You To Do

Execute required activities as part of ISO 27001 and ISO 62304 compliance
Create, revise, and maintain relevant policies and procedures.
Provide support for internal and external compliance audits.
Perform periodic assessments and risk evaluations.
Undertake activities relating to regulatory submissions for software as a medical device

Requirements

The candidate must have the ability to execute tasks and document information independently.

Have an understanding of medical devices, quality assurance and quality checks

Awareness of ISO 27001 and ISO 62304.

Internal auditor certification for ISO 27001 and ISO 62304 is preferable.

An understanding of regulatory pathways is preferable.

Skills

Keen attention to details.
Ability to critically evaluate scientific literature and integrate information from multiple sources..

Ability to work independently with minimal supervision as well as collaboratively in a team environment.

Excellent organizational and time management skills with the ability to prioritize tasks effectively

Strong interpersonal and communication skills with the ability to interact professionally with diverse stakeholdersSkills: time management,interpersonal skills,regulatory submissions,organizational skills,internal auditing,quality assurance,iso 27001 standards,iso 27001,documentation,critical evaluation of scientific literature,attention to detail,communication skills,risk evaluations,iso 62304

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Assistant Manager Quality and Regulatory