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Product Complaint - P3 at Boston Scientific Corporation Malaysia

Heredia, , Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

07 Apr, 26

Salary

0.0

Posted On

07 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Clinical Knowledge, Data Gathering, Complaint Investigation, Team Supervision, Professional Development, Report Writing, Decision Models, Quality Standards, Patient Safety, Communication, Collaboration, Analytical Skills, Problem Solving, Product Knowledge, Engineering

Industry

Medical Equipment Manufacturing

Description

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 and approve Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities. 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%. 1 year or more in current position. Annual Performance evaluation rating "Meets Expectations" or "Exceeds Expectations". Or an equivalent combination of education and experience.

Responsibilities

Oversee daily operations and ensure adherence to quality standards and regulatory requirements. Review and investigate product complaints, assess regulatory compliance, and write necessary reports.