Regulatory Affairs Specialist

4 days ago


Fremont, California, United States Infojini Consulting Full time
Regulatory Affairs Specialist

Infojini Consulting is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will play a critical role in ensuring the compliance of our medical devices with EU IVD regulations.

Key Responsibilities:
  • Assist in the preparation of regulatory submissions for IVDR implementation, including toxicology and therapeutic drug monitoring assays.
  • Organize and review materials for inclusion in regulatory submissions, both in the EU and worldwide.
  • Support the preparation of dossiers and submission packages for regulatory agencies, including IVDR technical dossiers for CE Mark approval.
  • Coordinate with partner channel regulatory colleagues to obtain product approvals.
  • Maintain regulatory documentation in accordance with department and company procedures, including logs and trackers.
  • Request and track document legalization, apostille, and certificates from regulatory agencies.
  • Process change orders for approval of documentation in electronic records management systems.
Requirements:
  • Bachelor's degree in a relevant field, preferably science or engineering.
  • Excellent understanding of EU IVD regulations.
  • Strong verbal and written communication skills, with attention to detail.
  • Ability to multitask, prioritize, and meet deadlines in a timely manner.
  • Strong organizational skills, with the ability to handle multiple assignments simultaneously.
  • Excellent verbal communication skills, with the ability to effectively communicate at multiple levels in the organization.


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