Regulatory Affairs Coordinator

Mindlance; Los Angeles (CA); On-site; USD 46,838 - 53,726; Full time

Job summary

A staffing agency in Los Angeles is seeking a detail-oriented professional to review Electronic Instructions for Use (IFUs) as part of the Localization Team. The role involves verifying information such as titles and model numbers, ensuring alignment with regulatory standards before publication. Candidates should possess strong data entry skills and a Bachelor’s degree with related experience. Join a growing team to contribute to crucial quality assurance processes in the industry.

Qualifications

• Must communicate outside of the small group.
• IFUs experience is beneficial but not required.

Responsibilities

• Review Electronic IFUs submitted by Writers and Localization Team.
• Check for issues on forms and ensure alignment for approval.
• Forward records to Regulatory Affairs for review.

Skills

Data Entry

GDP (Good Documentation Practices)

Attention to detail

Excellent communication

Prioritization

Education

Bachelor’s degree with 2 to 5 years of experience

Masters if they have some of the experience needed

Equivalent of education and work experience

Job description

Overview

This range is provided by Mindlance. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$34.00/hr - $39.00/hr

Location: In Person-100 Percent Onsite 15900 Valley View Court Sylmar, CA

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 her, management, and one other team member - via Teams Video Conference

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”

If you are inclined, I would be happy to set up some time to chat more about your background and career interests to see if there could be a possible match. Please feel free to call me on 732-806-7467 or send me email on [e-mail]

Regards

Niraj kumar