Date: Oct 12, 2018
Location:Valencia, CA, US, 91355
Company: Boston Scientific
Additional Locations: US-CA-Los Angeles; US-CA-Ventura County
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 purposeimproving lives through your life's work.
About the role:
Owns and maintains high risk product complaints within the complaint handling system. Investigates and resolves product complaints. Maintains regulatory reporting requirements per country specific regulations.
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.
Write regulatory reports for adverse events and/or malfunctions and ensure timely submission to the appropriate regulatory authorities.
Apply codes to complaints to facilitate product performance records. Review coding and investigations with engineering, laboratory, and other internal staff.
Work with cross functional teams to ensure accuracy within your complaint and process.
Be a proactive thinker and actively communicate issues or potential improvements that may benefit the immediate or cross functional teams.
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:
Bachelor's degree or higher from an accredited institution
1+ years of experience in a regulated environment.
Intermediate level ability to use most MS tools (Word, Excel, PowerPoint, Outlook, etc.)
Strong communication skills
Bachelor's degree in nursing, engineering, biology, physiology, or related
Excellent verbal and written communication skills
Experience with medical terminology or medical products
Experience in complaint handling and MDR filing in the medical device industry.
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: 436280
Nearest Major Market: Los Angeles
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