Job Description

Job Description

Duration: 12 Months

Description:

Nature of Role:

• Reviewing Electronic IFU (Instructions for Use) submitted by Writers and Localization Team.
• This worker will not be writing but only reviewing the IFUs and processing in system called Informatica and AEM for distribution.
• Will be reviewing the requests and checking for issues on forms, asking questions of the Regulatory Affairs team, MES, Engineers, etc to ensure alignment in preparation for approval.
• Information reviewed will include titles, production #s, dates, model #s, pdfs to ensure these are correct and align with the business unit so if any IFUs need to be removed they are detected.
• Records will be forwarded to Regulatory Affairs for review and approval and ultimately be published to the website.

Skill Needed:

• Data Entry, GDP (Good Documentation Practices), attention to detail, excellent communication, and prioritization, ability to identify urgent reviews, previous writing, labeling or quality experience.
• Must be able to communicate outside of the small group

Education:

• Bachelor’s degree with 2 to 5 years of experience, Masters if they have some of the experience needed, or an equivalent of education and work experience as well as a H.S. graduate with 2 to 5 plus years of experience.
• Will consider persons that are "over-qualified"
• IFUs experience is not a requirement but is very beneficial
• Titles that might be relevant are Project Manager, Data Entry Analyst, Regulatory Affairs Specialist, Quality Analyst, Editor, Proof-Reader - as long as they meet the requirements of this role
• Any industry experience is fine if they meet the experience requirements for this role
• Conversion to FTE - Not sure at this time - this role is to add to a growing team that is expanding

Interview Process:

• 1 round with Manager, management, and one other team member - via Teams Video Conference

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Recruiter Details:

Name: Ashish

Email: [email protected]

Internal Id: 25-54540

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