Superior Jobs


Regulatory Affairs Professional 2

  • ID: 479007
  • Posted: 2/22/2021
  • Location: Norwood, MA
  • Category: Pro - Professional
  • Job Type: Temporary
  • Duration: 9 - 12 Months


Acara Solutions is looking for a Regulatory Affairs Professional for our Client located in Norwood, MA.
  • Represents Regulatory Affairs on Post-Market RA Team for the Point-of-Care Business Area.
  • Support International Product Registrations.
  • Completes regulatory documentation for CE Marking IVD medical devices (Technical File updates, Declaration of Conformity.)
  • Coordinates and tracks notarization and legalization of regulatory documents.
  • Notifies countries of product changes and collects registration information for product teams.
  • Interacts closely with multiple functions, including Manufacturing, R&D, Marketing, Logistics, Labeling etc.
  • Completes the review of promotional material and device labeling for regulatory compliance.
Pay and Benefits:
The salary for this position is $37.33 per hour (Max Pay rate).
Job Requirements

Required Skills / Qualifications:
  • Bachelor’s degree
  • Minimum of 2 years’ experience in Medical device industry and with technical design documentation
Preferred Skills / Qualifications:
  • Attention to detail, able to manage and track multiple requests at once.
  • Requests Certificates to Foreign Governments, Free Sale Certificates.
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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