Posted in Compliance 30+ days ago.
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Type: Full Time
Location: San Jose, California
Additional Locations: (n/a)
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
At Boston Scientific, you ll discover a place where you can find meaningful purpose, improving lives through your life's work. This role will lead the day to day activities for a post market team responsible for capital equipment and single use devices on a global basis reporting to the Product Complaint Manager. Opportunities to participate cross functional projects.
Analyzes customer complaints to determine which are regulatory reportable and is a key contact for activities with internal, field, and end use customers. Responsible for adherence to, and interpretation of, Good Manufacturing Practices (GMPs), complaint handling per the Code of Federal Register (CFR), and all other applicable international governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.
* Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
* Serves as internal consultant on regulatory issues, field actions, and report decision-making. External government contact person, in addition to writing, reviewing, and auditing departmental Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
* Is an expert in clinical settings related to product application. Evaluates identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis. Department mentor/trainer.
* Drives regulatory reporting decisions using event investigation and regulatory decision models. Writes and develops decision models with changes in product advances/therapies to uphold consistent compliance with government mandated regulations.
* Develop and deliver presentations to global regulatory agencies. Topics may include regulatory reporting strategies, compliance issues, or new initiatives such as Global Harmonization.
* Compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to internal and external stakeholders.
* Is an expert on the Post Market staff serving as a resource to promote development of team through helping think out processes, look up information, and direct guidance.
What we are looking for
* 10+ years industry experience in related roles
* Bachelor's degree
* Global complaint handling experience, including associated regulatory/vigilance reports, data analysis experience, mentoring experience, responding to Regulatory authority requests
* Medical device industry experience
* Auditor facing experience
* Mentoring/leading a team through change
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: 391175
Nearest Major Market: San Jose
Nearest Secondary Market: Palo Alto
Job Segment: Medical, Product Manager, Law, Medical Technology, Healthcare, Operations, Legal, Customer Service