Product Analyst II

Product Analyst II

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.

About the Role

Join a dynamic, fast-paced environment where you'll analyze customer complaints for the Urology Complaint Management Center (CMC), determining regulatory reportability and coordinating activities with internal teams, field personnel, and end-use customers. This role covers a variety of urology prostate health devices and surgical lasers. You'll ensure compliance with Good Manufacturing Practices (GMPs), Code of Federal Regulations (CFR), and other applicable governmental regulations. Clear communication of investigation results through regulatory reports and written correspondence is a key component of this role.

Responsibilities

• Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Apply clinical knowledge, as related to product application, to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Establish regulatory reportability decisions using event investigation and regulatory decision models.
• Participate in the development and modification of decision models in alignment with product advances and therapies to maintain consistent compliance with regulatory requirements.
• Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to appropriate regulatory authorities.
• Apply appropriate codes to events to support product performance tracking. Review coding and investigations with engineering, laboratory, and other internal stakeholders.
• Compose written communications detailing clinical observations, investigation findings, and/or product analysis and corrective actions, as applicable, to physicians and other end users.

Qualifications

Required qualifications:

• Bachelor's degree
• Minimum of 2 years' experience in medical device or pharmaceutical complaint processing and reporting

Preferred qualifications:

• Bachelor's degree in Biology, Health Sciences, Biotechnology, or Engineering preferred
• Experience with SAS, PowerBI, or TrackWise applications
• Self-motivated, goal-driven, and results-oriented team player
• Excellent written and verbal communication skills
• Ability to apply critical thinking
• Excellent time management

Refer to ID 85637583 when applying