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IVDR International Registration

at Acara Solutions in Newark, Delaware, United States

Job Description

Acara Solutions is looking for a Regulatory Affairs Professional- IVDR International Registration for our Client located in Newark, DE
Analyzes the requirements and prepares product related regulatory submissions.
Creates quality guidelines and work instructions relevant for maintaining regulatory compliance.
Identifies, analyzes, and implements country specific requirements necessary for product related submissions.
Plans and prepares product related submissions with client internal (Regional Units) or external organizations according to regulatory requirements.
Performs regulatory projects or acts as a member of the project steering group.
Submits needed documentation/information to local authorities or client internal.
Initiates and escalates necessary activities if deviations are identified.
Ensures creation of adequate documentation for audits/inspections.
Performs training within the organization in country specific regulatory requirements, if applicable.
Performs review of promotional material for regulatory compliance according to country specific requirements.
Represent the company in industry associations (Lobbying), if applicable.
"Expands 'Needs to consider processes and results, generated in other workflows and disciplines, implies conditions and environments, and values significance to contribute effectively to team results.
Pay and Benefits:

The Salary for this position is $33.65 per hour (Max Pay rate).


Required Skills / Qualifications:
At least a high school diploma or GED
Minimum of 3 years' experience in Regulatory Affairs Professional
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: 1044972

Posted On: Sep 22, 2022

Updated On: Oct 09, 2022