Regulatory Complaint Analyst I – Medical Devices (Hybrid)

Boston Scientific; Maple Grove (MN); Hybrid; USD 51.000 - 97.000; Vollzeit

Zusammenfassung

Boston Scientific is seeking a Product Complaint Analyst I to join its Urology Complaint Management Center. The role analyzes customer complaints in a fast-paced environment to determine regulatory reportability and coordinates with internal teams and end users.

The position supports CFR compliance and requires a Bachelor’s degree with strong written and verbal communication. The role is hybrid, requiring in-office presence at least three days per week, with relocation assistance not available

Qualifikationen

• Bachelor’s degree or equivalent education required.
• Excellent written and verbal communication skills are essential.

Aufgaben

• 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 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.

Kenntnisse

Excellent written and verbal comm

Ausbildung

Bachelor’s degree or equivalent education

Jobbeschreibung

Boston Scientific is seeking a Product Complaint Analyst I to join its Urology Complaint Management Center. The role analyzes customer complaints in a fast-paced environment to determine regulatory reportability and coordinates with internal teams and end users.

The position supports CFR compliance and requires a Bachelor’s degree with strong written and verbal communication. The role is hybrid, requiring in-office presence at least three days per week, with relocation assistance not available