Senior Medical Device Complaint & MDR Analyst

Boston Scientific Gruppe; Arden Hills (MN); Hybrid; USD 66,000 - 125,000; Full time

Job summary

Boston Scientific is seeking a Regulatory Complaint Specialist to support the Urology Complaint Management Center in a fast-paced environment. You will analyze customer complaints for regulatory reportability, gather data from multiple sources, and communicate investigations and outcomes to internal teams and end-use customers.

Role requires a university degree and at least 5 years of medical device complaint handling, with strong writing, communication, and critical thinking skills.

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.
• College degree with a focus in biology, health sciences, biotechnology or engineering.
• Experience with SAS, Power BI or TrackWise applications.
• Experience reviewing scientific literature.

Responsibilities

• Review complaint communications and assess regulatory compliance and reportability.
• Investigate complaints by gathering 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 advance to support compliant regulations.
• Write MDRs, MedWatch and other regulatory reports and transmit to authorities.
• Apply codes to events to facilitate product performance records and review with engineering and staff.
• Compose written communications detailing observations and actions for physicians and end-use customers.
• Review and approve work completed by the team.

Skills

Excellent written and verbal comms

Critical thinking

Self-motivated

Teamwork

Education

University degree or equivalent education

Biology/Health sciences/Engineering focus

Experience with medical devices

Tools

SAS

Power BI

TrackWise

Job description

Boston Scientific is seeking a Regulatory Complaint Specialist to support the Urology Complaint Management Center in a fast-paced environment. You will analyze customer complaints for regulatory reportability, gather data from multiple sources, and communicate investigations and outcomes to internal teams and end-use customers.

Role requires a university degree and at least 5 years of medical device complaint handling, with strong writing, communication, and critical thinking skills.