Medical Device Compliance Analyst I

Boston Scientific; Arden Hills (MN); Hybrid; USD 51,000 - 97,000; Full time

Job summary

Boston Scientific is seeking a Product Complaint Analyst I to work in the Urology Complaint Management Center, analyzing customer complaints for regulatory reportability and coordinating with internal teams and end users.

The role requires adhering to CFR and government regulations, writing reports, and operating in a hybrid model with in-office presence at least three days per week; relocation not offered and visa sponsorship not available.

Qualifications

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

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.

Skills

Excellent written and verbal comm.,

Education

Bachelor’s degree or equivalent education

College Degree focus in Biology Health Sciences Biotechnology or Engineering preferred

Job description

Boston Scientific is seeking a Product Complaint Analyst I to work in the Urology Complaint Management Center, analyzing customer complaints for regulatory reportability and coordinating with internal teams and end users.

The role requires adhering to CFR and government regulations, writing reports, and operating in a hybrid model with in-office presence at least three days per week; relocation not offered and visa sponsorship not available.