Product Complaint Analyst I

Boston Scientific • Arden Hills, MN

5d • $51,000 - $96,900 • Hybrid

About The Position

The Product Complaint Analyst I will analyze customer complaints to determine regulatory reportability and coordinate activities with internal teams, field representatives and end-use customers. This role is responsible for adherence to Good Manufacturing Practices (GMPs), proper complaint handling in accordance with the Code of Federal Regulations (CFR) and other applicable government regulations. The Product Complaint Analyst I will communicate event investigation results through regulatory reports and written communications, as appropriate. In all actions, the Product Complaint Analyst I will demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Requirements

• Bachelor's degree.
• Less than one year of experience.

Nice To Haves

• Experience in complaint handling.
• Experience writing or submitting Medical Device Reports (MDRs).
• Experience with medical devices; electrophysiology experience preferred.
• Experience working in a TrackWise-based complaint handling system.
• Experience with Microsoft programs, including Excel, Word and Outlook.
• Strong analytical and problem-solving skills.
• Excellent communication skills.
• Strong organizational skills and attention to detail.

Responsibilities

• Review complaint communications and assess regulatory compliance, reportability and potential impact on patient safety and business operations.
• Participate in the development and modification of decision models as products and therapies advance to maintain consistent compliance with government-mandated regulations.
• Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees and laboratory analyses.
• Collect, compile and document regulatory reportability decisions using event investigation and regulatory decision models.
• Draft Medical Device Reports (MDRs), MedWatch reports, Vigilance reports and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
• Apply codes to events to facilitate product performance records and review coding and investigations with engineering, laboratory and other internal staff.
• Draft written communications detailing clinical observations, investigations and/or product analyses and corrective actions, as applicable, for physicians and other end-use customers. Communications may include determinations of eligibility for warranty credit or unreimbursed medical payments.

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: Entry Level