Medical Device Document Specialist

3 days ago

Bengaluru, Karnataka, India beBeeDocumentControl Full time ₹ 13,56,000 - ₹ 20,24,000

Job Description:

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  • Manage labeling databases, track issues, and maintain Quality Systems Records (QSR) and related materials for the creation/revision and control of customer labeling, specifications, and documentation for regulatory submissions, tenders, and commercial labeling.
  • Document types can include specifications, SOPs, manuals, quick reference guides, inserts, eIFUs, other IFUs, and labels (boxes, cartons, variables, etc.).
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Purpose:

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This position will ensure compliance with ISO, cGMP, and FDA guidelines in managing documents to support Labeling Development within established formats and templates.

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Responsibilities:

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  • Manage documents to support Labeling Development in compliance with ISO, cGMP, and FDA guidelines, working within established formats and templates.
  • Complete Engineering Change Requests for Global Labeling & Packaging.
  • Initiate the collaborative review process and assist document users with inquiries and research.
  • Track documentation through the entire development process while adhering to strict timelines, maintaining revision control, maintaining change lists, and managing reviewers.
  • Expedite change request consideration and approval processes including coordinating reviews by stakeholders of project change requests, managing stakeholders and approvers for timely response on change management requests, and maintaining comprehensive change management files and documentation.
  • Effectively communicates activity status, issues, and mitigation plans with key stakeholders.
  • Identify areas for improvement (e.g., processes, styles, formats), and execute continuous improvement initiatives.
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Required Knowledge, Skills, and Abilities:

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  • Knowledge of Microsoft Office's suite of products and 3+ yrs of hands-on experience in a medical device document controller role.
  • Strong self-motivation and ability to work independently and in a team environment. Strong follow-up, organization, and prioritization skills.
  • Excellent communication skills, both written and verbal. Strong interpersonal skills: ability to learn new concepts quickly and manage multiple projects at once; comfortable with shifting priorities and schedules.
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