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Boston Scientific · 1 week ago

Product Complaint Supervisor

Arden Hills, MN

Full-time

Hybrid

Mid Level

$66K/yr - $125K/yr

3+ years exp

Boston Scientific is a leader in medical science committed to solving health industry challenges. The Product Complaint Supervisor oversees a team of product analysts, ensuring compliance with regulatory standards and effective handling of customer complaints.

Health CareMedicalMedical Device

No H1B

Responsibilities

Supervising a small team of product analysts to meet the objectives established by the Department Manager

Monitoring daily operations and work-in-progress (WIP) to ensure efficiency and adherence to quality standards and regulatory requirements

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

Qualification

Medical device experienceRegulatory complianceComplaint handlingSASPowerBITrackWiseLeadership experienceCommunication skillsTime managementOrganizational abilitiesTeam playerSelf-motivated

Required

Bachelor's degree, or an equivalent combination of education and experience in lieu of a degree

Minimum of 3+ years of medical device or regulated industry experience

Preferred

Degree in Biology, Health Sciences, Biotechnology or Engineering

Self-motivated, goal-drive, and results-oriented team player

Strong written and verbal communications skills

Direct or indirect leadership experience

Prior complaint handling experience

Excellent time management and organizational abilities

Experience with SAS, PowerBI, or TrackWise applications

Experience with Electrophysiology products

Benefits

Compensation may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).