Product Complaint Analyst II

Boston Scientific • Arden Hills, MN

7d • $59,900 - $113,800 • Hybrid

About The Position

The Product Analyst II analyzes customer complaints to determine regulatory reportability and coordinates complaint-related activities with internal stakeholders, field personnel and end-use customers. This role is responsible for ensuring compliance with Good Documentation Practices (GDPs), complaint handling requirements and applicable U.S. and international regulatory requirements. The Product Analyst II communicates event investigation results through regulatory submissions and written customer communications, as appropriate, while maintaining a strong commitment to patient safety and product quality.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Requirements

• Bachelor’s degree.
• Minimum of 2 years' experience in a health care, clinical, technical, scientific or related field.

Nice To Haves

• Knowledge of peripheral and interventional cardiology medical devices.
• Experience using a TrackWise-based complaint handling system.
• Experience preparing and submitting Medical Device Reports (MDRs) and vigilance reports.
• Experience evaluating and investigating patient complication or death events.
• Medical device industry experience.
• Experience in post-market surveillance, quality systems or complaint handling.
• Strong attention to detail and organizational skills.
• Strong critical-thinking and problem-solving abilities.
• Excellent written and verbal communication skills.
• Self-motivated, goal-driven and results-oriented team player.

Responsibilities

• Apply policies and procedures to ensure compliance with FDA and international regulatory requirements.
• Evaluate incoming complaint information to determine Medical Device Reporting (MDR) and vigilance reporting eligibility.
• Ensure complete, accurate and timely submission of Medical Device Reports (MDRs) and vigilance reports.
• Interface and collaborate with internal and external stakeholders to efficiently collect complaint-related information.
• Complete required compliance and regulatory training in a timely manner.
• Maintain awareness of new products, regulatory requirements and industry developments.
• Communicate investigation findings through written correspondence and regulatory submissions, as appropriate.
• Support departmental and divisional objectives while maintaining high standards of quality and compliance.
• Perform additional duties and responsibilities as assigned.

Benefits

• The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
• Compensation for non-exempt (hourly), non-sales roles 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 for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level