Medical Device Regulatory Analyst

hace 5 días


Tijuana, Baja California, México Baxter A tiempo completo
About Baxter

Baxter is a leading medical device company that has been pioneering significant innovations in healthcare for over 90 years.

Our mission is to improve patient outcomes and quality of life through the development of life-saving and life-changing products and therapies.

Job Overview

We are seeking a highly skilled Medical Device Regulatory Analyst to join our team. This role will be responsible for managing potentially reportable event workflow and processes, ensuring complaint records accurately reflect the allegation, investigation, and conclusion of customer complaints.

The ideal candidate will have excellent analytical and problem-solving skills, with the ability to work independently and collaboratively as part of a team.

Key Responsibilities
  • Manage potentially reportable event workflow and processes within software based on an understanding of the risks associated with product malfunction.
  • Ensure complaint records accurately reflect the allegation, investigation, and conclusion of customer complaints.
  • Work independently and with different parts of the organization to resolve complex issues.
  • Identify the need for and request engineering investigation reviews to identify the root cause for identified malfunctions.
  • Ensure timely closure of complaints to comply with regulatory requirements.
Requirements
  • An associate degree or a minimum of 6 months to 1-year previous related work experience in the medical device industry or equivalent combination of education and experience.
  • Must be fluent in both speaking and writing in English.
  • Good written and verbal skills, as well as good interpersonal, analytical, and organizational skills.
  • Experience in resolving issues for internal and external customers.
  • Ability to work within deadlines and work on multiple projects accurately and efficiently.
Compensation

The estimated salary for this role is between $65,000 - $85,000 per year, depending on experience.

Benefits

Baxter offers a comprehensive benefits package, including medical, dental, and vision coverage, 401(k) matching, and paid time off.



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