Davis Companieshttp://daviscos.com/wp-content/themes/davis_theme/assets/images/logo.svg325 Donald J. Lynch Boulevard, Suite 201MarlboroughMA01752USAcustomer support[+800-482-9494][+508-481-8519]
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Regulatory Affairs Associate

  • Specialty:

    Engineering
    • City:

      Alpharetta
    • State:

      GA
    • 30005
  • Assignment Type:

    Direct Hire
  • Job Id:

    59971

Description

Regulatory Affairs Associate
The Regulatory Affairs Associate will support, conduct, compile, and review document change notifications for regulatory compliance. This is a direct hire opportunity to join a leading-edge medical device company.

Salary Range: 55-65k

Responsibilities:

  • Support the delivery of regulatory applications for national and international approvals. (FDA 510k, IDE, PMA)
  • Compile US FDA, EU and other regional labeling information.
  • Submit the appropriate labeling (UDI) to the corresponding labeling database.
  • Conduct research to develop additional regulatory knowledge worldwide guidelines based on business needs.
  • Review document change notifications for compliance.
  • Review design and manufacturing process changes for significant changes which require notification.
  • Providing support to the Engineering and R&D teams when it comes to interpretation of regulatory requirements, documents, and other standards.
  • Maintain regulatory Affairs files per requirements.
  • Support QMS and RA projects to achieve compliance with new or revised requirements.

Requirements

  • BS degree in Engineering (or related discipline) or education/experience equivalency
  • 3-5 years of U.S or International or both regulatory requirements experience.
  • 1+ year experience with Class 1 or class 2 medical device products and regulations.
  • High level of competency in FDA QSRs, ISO 13485, and other regulatory requirements.
  • Excellent communication, organization, and prioritization skills.
 
DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace.  We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be.  Apply today and experience “The DAVIS Difference”. 

Quick Apply

  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
  • Accepted file types: pdf, doc, docx, txt, rtf.
  • By applying to this position and providing my contact information, I give The DAVIS Companies permission to provide me with email communications and information.

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