Regulatory Affairs Associate
Posted on :
14-10-2022
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Job Description
Responsibilities:
- Responsible for document formatting of Word documents using authoring templates and authoring systems/tools. Updates documents based on direction from RA Managers
- Creates submission-ready Regulatory documents not auto-rendered in eDocs (e.g., for PDF source files, ensuring correct version of PDF, contains bookmark(s), inherit zoom, etc.)
- Performs document management tasks (e.g., importing/exporting documents into eDocs, entering metadata, routing for review/approval, etc.).
- Sets up RA team site for marketed products, uploads blank templates and/or current documents for revision, maintains cleanup site after document completion.
- Adapts to changes resulting from changing timelines, priority shifts, software updates, and changes in business processes.
- Prioritizes multiple tasks/projects with strong organizational skills and maintains effective interaction with RA professionals.
- Receives project assignments from RA Managers but has responsibility for managing projects and timelines independently. Elevates issues to manager as appropriate in a timely manner.
- Tracks and reports departmental metrics for document specialist tasks. Identifies, suggests, and may assist in the implementation of process improvements.
- Acts as the recognized expert on the use of eDocs within RA.
- Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
- Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
- Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices.
- May require an advanced degree and 5-8 years of direct experience in the field.
- Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
- Relies on extensive experience and judgment to plan and accomplish goals.
- Performs a variety of tasks.
- May lead and direct the work of others.
- A wide degree of creativity and latitude is expected.
- Typically reports to a manager or head of a unit/department.
- Required Education: High School diploma or equivalent and four years of related experience
- Preferred Education: Bachelor's degree
- Required Experience: Four years of pharmaceutical or industry related experience.
- Expert user of Word, Adobe, document management system, authoring tools
- Minimum 2 years' experience in managing or essential documents or equivalent
- Preferred Experience: Word processing knowledge and experience with Microsoft Office products (Word, Excel and PowerPoint)
- NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.
Employment Type
Full Time
Key Skills
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