LSI Solutions Inc-posted 3 months ago
$25 - $28/Yr
Full-time • Entry Level
Victor, NY

We are seeking a person who is highly organized and detail-oriented to become a Regulatory Coordinator to support the smooth operation of our department. In this role, you will be responsible for managing various administrative tasks, ensuring the efficient flow of work, and providing support to our team and management. The ideal candidate will possess strong administrative skills, including proficiency in Microsoft Office, document preparation, and organizing and maintaining a master scheduling document. You should have a can-do attitude, be proactive in identifying needs, and show a commitment to getting tasks done on time. The ability to stay focused in a fast-paced environment while juggling multiple responsibilities is essential. If you are a self-starter with exceptional organizational abilities and a passion for delivering high-quality work, we want you to join our team! We are prepared to train the right candidate to transition into the world of regulatory.

  • Understand and maintain LSI file structures and locations for controlled documents and the Regulatory Drive.
  • Obtain apostilling on necessary regulatory documentation.
  • Prepare attachments and hyperlinks for submissions to regulatory agencies, notified body, competent authorities, and/or authorized representative.
  • Complete all assigned quality management system training on schedule.
  • Perform regulatory intelligence monitoring on a regular basis, documenting and distributing results as directed.
  • Understand the commercial release authorization process and update commercial release authorizations as directed.
  • Support internal and external audits and compliance assessments.
  • Act as coordinator for receiving, processing, tracking, investigating, and reporting of customer complaints from initiation to closeout.
  • Prepare and send complaint response letters as directed.
  • Prepare and submit timely customer response communications to report results of investigations in a professional manner.
  • Search the MAUDE database for adverse events.
  • Process complaint device return and tracking.
  • Gathers registration materials as requested by distributors, with direction.
  • Communicates with distributors for ROW medical device registration, with direction.
  • Maintains the ROW Regulatory docket.
  • Complete labeling review checklists.
  • Keep up to date with the global regulatory developments of new regulations, standards, policies, and guidance’s issued by regulatory authorities that may have impact to the company.
  • Perform all other responsibilities as assigned.
  • Bachelor’s Degree or 5-10 years of administrative experience with 3+ years of experience handling medical complaints and/or medical records.
  • A rudimentary understanding of Regulatory principles that govern medical device companies.
  • 1-2 years of experience working as a Regulatory Coordinator at a medical device company operating within a Quality Management System (QMS) certified to ISO 13485.
  • Familiar with 21 CFR 820, 21 CFR 803, and ISO 13485.
  • 2-3 years of experience working as a Regulatory Coordinator at a medical device company operating within a Quality Management System (QMS) certified to ISO 13485, said experience relevant to and demonstrating effective performance related to the Regulatory Coordinator III Essential Functions listed above.
  • Familiar with Canadian, European, Japanese, Australian, and Brazilian adverse event reporting requirements for medical devices.
  • Bonus Plan
  • 401(k) plan with company match
  • Tuition Assistance
  • Employee Assistance Program (EAP)
  • Product Discounts
  • 15 Paid Holidays
  • PTO
  • Sick Time
  • Medical, Vision and Dental effective first day of employment
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