Medical Device Specialist
hace 3 semanas
About the Role: We are seeking a highly skilled Medical Device Specialist to join our team. As a Medical Device Specialist, you will be responsible for analyzing customer complaints to determine which are regulatory reportable and coordinating activities with internal, field, and end-use customers.
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 transmission 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: We are seeking a highly skilled Medical Device Specialist with a Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or a related field. At least 2 years of experience in similar positions, English language proficiency at a level of 70-79%, and 1 year or more in the current position. Annual Performance evaluation rating "Meets Expectations" or "Exceeds Expectations" or an equivalent combination of education and experience.
About Us: Boston Scientific is a global leader in medical science, 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.
Benefits:
- Life-Work Integration
- Community
- Career Growth
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