Product Complaint Analyst II

Additional work locations: Arden Hills, MN; Irvine, CA; Marlborough, MA; Maple Grove, MN.

About The Role

The Product Complaint Analyst II will work in a fast-paced environment to analyze customer complaints for the Urology Complaint Management Center (CMC) to determine which are regulatory reportable and will coordinate activities with internal, field, and end-use customers. The focus of this role will be products within the Urology portfolio. The Product Complaint Analyst II will be responsible for adhering to proper complaint handling procedures per the Code of Federal Regulations (CFR) and other governmental regulations. This role follows a hybrid work model requiring employees to be in the local office at least three days per week. Relocation assistance and employment visa sponsorship are not available for this position.

Responsibilities

• Review complaint communications and assess complaints for regulatory reportability, and potential impacts to patient safety and business operations.
• Apply clinical knowledge, as related to product usage, to evaluate complaints.
• Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, laboratory analysis results, and other relevant sources.
• Establish 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), Vigilance, and other regulatory reports, ensuring timely submission to the appropriate regulatory authorities.
• Accurately and consistently apply codes to events. Review coding and investigations with engineering, laboratory, and other internal staff, as appropriate.
• Effectively compose written communication, detailing the clinical observations, investigations and/or product analyses and corrective actions, as applicable, to physicians and other end-use customers.

Qualifications

Required Qualifications

• Bachelor’s degree or equivalent education.
• 1+ years of experience in medical device complaint processing & reporting.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Self-motivated, goal-driven, and results-oriented team player.
• Critical thinking and good time management skills.
• College degree focus in Biology, Health Sciences, Biotechnology, or Engineering.

Pay

The anticipated salary range for this role is $59,900 – $113,800. Compensation will be commensurate with experience, education, and relevant business or organizational needs. Non-exempt (hourly) roles may also include variable compensation such as overtime, shift differential, and annual bonus. Exempt roles may include variable compensation such as annual bonus and long-term incentives.

Benefits

Boston Scientific offers a comprehensive benefits package, including core and optional employee benefits. For more details, visit www.bscbenefitsconnect.com.