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IVDR Regulatory Affairs Professional

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  • ID: 492125
  • Posted: 9/15/2021
  • Location: New Castle, DE
  • Category: Pro - Professional
  • Job Type: Temporary
  • Duration: 9 - 12 Months

Description

Acara Solutions is looking for an IVDR Regulatory Affairs Professional for our Client. Worker can be located in Newark, DE or Tarrytown, NY.
  •   The position will initially be remote until we can return to the office.
  • Support the regulatory activities needed to comply with the European In Vitro Diagnostic Regulation (IVDR 2017/746) by performing the following-Create and review technical documentation for reagents, calibrators, controls, and other in vitro diagnostic products to comply with European In Vitro Diagnostic Regulation (2017/746/EU).
  • Gather regulatory documents and information to support creation of technical documentation.
  • Identify and close gaps in technical documentation.
  • Work collaboratively to complete tasks, both within regulatory affairs and with other departments.
  • Create, review, and route for approval EU Declarations of Conformity.
  • Provide periodic progress reports to supervisors.
  • Attend in-person and teleconference meetings as assigned.
  • Prepare finished IVDR technical documentation for submission to the Notified Body.
  • Prepare quality records for electronic archival.
 
Pay and Benefits:
 The salary for this position is $33.00 per hour
 
Job Requirements

 
Required Skills / Qualifications:
  • Bachelor of Art/Science in a Science related field.
  • Minimum 2 years of Regulatory Affairs experience in an industry such as pharmaceuticals, medical devices, or in vitro diagnostics.
Preferred Skills / Qualifications:
  • Proficiency with Windows and Microsoft Office (especially Microsoft Word and Excel).
  • Great time management and organizational skills.
  • Experience with and knowledge of (a) the European In Vitro Diagnostics Medical Devices Directive (IVDD 98/79/EC) or (b) the European In Vitro Diagnostic Regulation (IVDR 2017/746).
  • Experience with SAP.
  • Experience with medical device labeling review.
  • Regulatory Affairs experience with in vitro diagnostics.
  • Proficiency with Windows 10 and Microsoft Office 365.       
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.
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