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Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

About the role

• Investigates and resolves product complaints of all products and maintains Medical Device Reporting (MDR) Requirements. Maintains Product Complaint/MDR data base and develops complaint trend analysis.

Your responsibilities include:

• 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 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), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmition 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 the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers. 

What we're looking for

Basic Qualifications:

• High School diploma or equivalent
• Minimum of 6 months experience in complaint handling and MDR filing in medical device or pharma industry
• Intermediate level ability to use most MS tools (Word, Excel, PowerPoint, Outlook, etc.)

Preferred Qualifications:

• Bachelor’s degree in nursing, engineering, biology, physiology, or related
• Excellent verbal and written communication skills
• Experience with medical terminology or medical products

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

Requisition ID: 451641