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Regulatory Operations

2 months ago

Irvine, United States redbock Full time

Sr. Regulatory Operations Spec. (Through end of April 2025 // Irvine, CA):

HM's Top Needs:

  1. Regulatory Operations experience in medical device industry including submission publishing, device listings, CFGs, UDI data collection & reporting, QMS updates.
  2. Experience with RIM systems & tools, reporting tools such as Power BI, Business Objects, regulated master data management
  3. Understanding of Medical Device regulations in US & EU including types of submissions, change notifications, new & changing regulations assessments.


Description:

Sr. Regulatory Operations Specialist would lead the submission content management, submission publishing in US & EU, regulated master data management including UDI data collection & submission, new & changing regulations assessment, regulatory processes & QMS procedure updates. This person would be responsible for maintaining device listings, product licensing, facility registrations and providing audit support for FDA, NB & International agency audits. The Sr. RA Ops Specialist will be highly collaborating with cross-functional team in preparing submission content and keeping up overall regulatory compliance.


Education Required: Bachelor’s degree

Years’ Experience Required: 3-4 years


Duties:

  • Responsible for the preparation, publication, quality control, and delivery of paper and electronic components of all submissions including initial large marketing authorization applications and electronic common technical documents (eCTD). Submissions are produced with electronic publishing tools in compliance with document management standards.
  • Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.
  • Ensures continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.
  • Prepares, submits, tracks, indexes and archives paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials


Job Qualifications:

  • Bachelor's degree in a relevant field, such as life sciences, engineering, or business administration.
  • Experience in UDI data collection and submission preferred, but not required
  • Experience with US/EU submission strategy and activities.
  • Excellent communication, organizational, and problem-solving skills.
  • Attention to detail and accuracy.
  • Ability to work independently and collaboratively in a fast-paced environment.
  • Proficient in Microsoft Office applications, such as Word, Excel, and PowerPoint.