Expoint - all jobs in one place

מציאת משרת הייטק בחברות הטובות ביותר מעולם לא הייתה קלה יותר

Limitless High-tech career opportunities - Expoint

Boston Scientific Analyst III Product 
Costa Rica, El Amparo 
503988921

28.06.2024

Hybrid Roles:

Your Responsibilities Include:

  • Overseeing daily operations and work-in-progress (WIP) to ensure efficiency and adherence to quality standards and regulatory requirements.
  • Supervising a small team of analysts.
  • Supporting the professional development of individual contributors, helping them grow their skills and advance their careers.
  • Coordinating efforts with corporate partners and liaising with multiple geographical locations to align strategies and achieve common goals.
  • Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
  • Apply clinical knowledge, as related to product application, to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
  • Establish and approve regulatory reportability decisions using event investigation and regulatory decision models.
  • Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
  • Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.

What We’re Looking For:

  • Bachelor or Licentiate’s degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related Health Field.
  • At least 2-3 years of experience in similar positions
  • English Level desired: 80% - 90%.
  • Or an equivalent combination of education and experience.