Regulatory Reporting Analyst-Gobal Compliants

3 weeks ago


Plymouth, United States Fastnet Software International Inc Full time
Job DescriptionJob Description

Note--- This role will be onsite for the first few weeks for training. From there, it will largely be remote, but may need to come onsite time to time as the business needs. This is why we're looking for candidates in the Minneapolis and Salt Lake City areas.

Must-Have:

  • Bachelor’s Degree in Engineering, Medical Sciences, or other related scientific field required.
  • 2+ years’ experience in a health care environment, and/or within a quality/compliance/regulatory organization in an FDA-regulated business preferred.
  • US FDA Medical Device Reporting and experience with Trackwise Digital preferred.

Work Environment

  • • This is largely a sedentary role.
  • • This job operates in a professional office environment and routinely uses standard office equipment.

Responsibilities:

  • The temporary position is responsible for managing device complaints and adverse events globally.
  • This may include complaint initial triage, submitting regulatory reports by applicable regulations, referring potential safety cases to applicable departments, providing updates to reports, reviewing for closure/reopening as needed, and assuring timely processing of complaints.

Essential Duties & Responsibilities

  • • Responsible for evaluating complaints from a patient safety perspective and completing regulatory reporting decisions per reporting requirements globally.
  • • Responsible for creating and submitting regulatory reports to the FDA.
  • • Works independently and is accountable for completing tasks as assigned.
  • • Works well in a team to accomplish team goals.

Knowledge & Skills

  • • Experience with or knowledge of medical terminology and how medical/pharmaceutical products are typically used in a clinical setting.
  • • Basic computer and software skills.
  • • Must be able to communicate effectively with internal and external customers.
  • • Demonstrate ability to collect, analyze and interpret complaint and adverse event information.
Company DescriptionFastnet Software International Inc is a NY-based legitimate staffing organization.
We are fine to provide any required information if any job seeker wants before submitting the resume for an interesting job.Company DescriptionFastnet Software International Inc is a NY-based legitimate staffing organization. \r
We are fine to provide any required information if any job seeker wants before submitting the resume for an interesting job.
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