What are the responsibilities and job description for the Regulatory Affairs Coordinator position at Mindlance?
* 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 nirajk@mindlance.com
Regards
Niraj kumar
Salary : $34 - $39