Senior Medical Device Complaint Analyst

Boston Scientific; Maple Grove (MN); Hybrid; USD 66,000 - 125,000; Full time

Job summary

Boston Scientific in Minnesota is seeking a Regulatory Affairs professional to support the Urology Complaint Management Center in a fast-paced environment. You will analyze customer complaints to determine regulatory reportability and coordinate with internal teams, field representatives, and end-use customers.

The role emphasizes GMP adherence, CFR compliance, and timely regulatory reporting; hybrid work with in-office presence at least three days weekly; opportunities for growth within a

Qualifications

• University degree or equivalent education.
• Minimum of 5 years' experience in medical device complaint handling.
• Self-motivated, goal-driven and results-oriented approach with the ability to work effectively as part of a team.
• Excellent written and verbal communication skills.
• Ability to apply critical thinking and strong time-management skills.

Responsibilities

• Review complaint communications and assess regulatory compliance, reportability and potential impact on patient safety and business operations.
• Apply clinical knowledge related to product applications to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees and laboratory analyses.
• Establish regulatory reportability decisions using event investigation and regulatory decision models.
• Participate in the development and modification of decision models as products and therapies advance to support consistent compliance with government-mandated regulations.
• Write 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. Review coding and investigations with engineering, laboratory and other internal staff.
• Compose written communications detailing clinical observations, investigations and/or product analyses and corrective actions, as applicable, for physicians and other end-use customers.
• Review and approve work completed by the team.

Skills

Regulatory compliance

Team collaboration

Written communication

Critical thinking

Time management

Education

University degree or equivalent

Bachelor's degree or higher

Tools

SAS

Power BI

TrackWise

Job description

Boston Scientific in Minnesota is seeking a Regulatory Affairs professional to support the Urology Complaint Management Center in a fast-paced environment. You will analyze customer complaints to determine regulatory reportability and coordinate with internal teams, field representatives, and end-use customers.

The role emphasizes GMP adherence, CFR compliance, and timely regulatory reporting; hybrid work with in-office presence at least three days weekly; opportunities for growth within a