Regulatory Affairs Specialist

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  • 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.
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Regulatory Affairs Specialist

  • Specialty:

    Scientific
  • Title:

    Regulatory Affairs Specialist
    • City:

      Chaska
    • State:

      MN
    • Zip Code:

      55318
  • Start date:

    07-24-2020
  • Status:

    Closed
  • Assignment Type:

    Contract To Hire
  • Job Id:

    53964

Description

The DAVIS Companies has partnered with a leader in Biomedical Manufacturing to identify a Regulatory Affairs Specialist to join their team! This position is remote. 

The Senior Regulatory Affairs Representative plans, coordinates, facilitates, and reports on regulatory programs. The primary responsibilities will be the evaluation, coordination, preparation and implementation of post-market Regulatory Affairs activities.

Responsibilities of the Regulatory Affairs Specialist: 

  • Administration of the company’s complaint management program for compliance to corporate requirements.
  • Planning and implementing pre-market registration, reporting and compliance activities in accordance with the development center business plans.
  • Implementing global regulatory compliance programs for product corrective action and/or adverse event reporting.
  • Preparing premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments.
  • Additionally may provide assistance to technical departments, manufacturing business centers and suppliers in the creation and structuring of clinical data for pre-market notifications.
  • Functioning as a team expert for promotional materials review, experimental designs, data analysis and product labeling as they relate to registration and commercialization of medical devices.

Education and Experience Requirements of the Regulatory Affairs Specialist: 

  • Bachelor’s degree in field with 5+ years of experience OR Master’s degree in field with 3+ years of experience.
  • Regulatory experience required.
  • Experience with IVD is required

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