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Regulatory Affairs Professional

at Acara Solutions in Newark, Delaware, United States

Job Description

Acara Solutions is looking for an Regulatory Affairs Professional for our Client located in Newark, DE
Member of the IVDR RA international team and responsible for preparing and providing documents for registering assays and instruments worldwide.
Review design changes and obtain supporting documentation (reports) from SAP/Documentum.
Transcribes information on a design change into a letter of explanation.
Dialogues with country RA to answer questions from country regulatory authorities on IVDR labeling changes.
This includes dialoguing with other departments for additional information, locating data within reports and writing explanation letters.
Submits documents for legalization/apostille and manages the process.
Works in TEAMS and SharePoint to upload labeling and documents.
Maintains spreadsheets of data; manipulates the data into summaries, pivot tables and graphs for reporting.
Pay and Benefits:

The Salary for this position is $ 35.00 per hour(Max Pay rate).


Required Skills / Qualifications:
Bachelor's Degree
Minimum of 3 years' experience in w/medical devices
Minimum of 1 year experience in RA.

Preferred Skills / Qualifications:
Medtech background or laboratory experience
Able to write clear, concise and sometimes technical explanations to bridge gaps between existing documents and country requirements.
Good working knowledge of Office applications, Outlook, Adobe Acrobat, TEAMS, SharePoint
Additional Information:

Upon offer of employment, the individual will be subject to a background check and a drug screen

Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron's strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.

Aleron companies; Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, Viaduct, and Aleron's strategic partner, SDI are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis.

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Job Posting: 900695

Posted On: Jan 22, 2022

Updated On: Feb 21, 2022