Regulatory Affairs Specialist

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Regulatory Affairs Specialist

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    Regulatory Affairs Specialist
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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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