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Regulatory Affairs Specialist

Expired Job

Varite Batesville , IN 47006

Posted 6 months ago

Regulatory Affairs SpecialistReq I D

HR-01149

Rate

Primary Skills

Description

Job summary:

In this role you will conduct gap assessments of, and develop a remediate plan for, our Supplier files and Clinical Evaluation Reviews against the new EU MDR. Your experience with the medical device industry and regulation will serve you well in this role. Leveraging our SMEs, documentation, and processes you'll provide a thorough and detailed report of identified gaps and necessary steps for remediation. Regular status updates and communication with the team regarding the progress of analysis will keep our project on track.

Skill/Experience/Education

Mandatory:

  • MDD, MDR, ISO13485:2016, ISO9001:2015 training/certification

  • Excellent written and oral communication skills

  • Team player with attention to detail

  • Experience in the medical device industry

  • Bachelor's Degree

  • Self-motivated with high performance standards

Ideal Candidate:

  • Preferred: Previous work with Notified Bodies

  • Preferred: EU MDR expertise

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Regulatory Affairs Specialist

Expired Job

Varite