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Product Analyst I Job

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Date: Oct 1, 2021

Location: Valencia, CA, US, 91355

Company: Boston Scientific

 

 

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

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 this role:

Boston Scientific Neuromodulation, a leading producer of medical devices for neuromodulation is looking for a CMC Product Complaint Analyst to work in a team environment with members of the Global QA-Post Market Surveillance group.  Specifically, work in a team of Complaint analysts in the Complaint Management Center who disposition, manage, and close product complaints associated with medical devices.  In this role you will work closely with Patient Care, Complaint Investigation Site and Complaint Call Center areas to manage all customer complaints, as required by regulatory agencies.  The position will support post market and clinical studies.  Must be able to work well in a team environment, foster team building, proactively communicate project and task status, and operate with a high level of initiative.  Possess excellent verbal communication and critical thinking skills and good technical writing skills.

 

 

Your responsibilities will 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.
  • Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transition to the appropriate regulatory authorities.
  • Interfaces with Field Staff, Customer Service, Patient Care, Legal, Field Inventory Team, Complaint Investigation Site, Quality Assurance to investigate complaint
  • Run basic complaint handling reports from the complaint handling database.

 

 

What we’re looking for in you:
Minimum Qualifications

  • Minimum 1 year of office experience in regulated environment reviewing and processing documents
  • High School diploma or equivalent

Preferred Qualifications

  • Minimum 2 years’ experience supporting post-market activities in a FDA regulated industry OR certified ISO environment
  • Bachelor's degree
  • Experience processing complaints
  • Experience in technical writing

 

 

 

 

 

Requisition ID: 502638

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.


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