Regulatory Compliance Specialist
hace 6 días
Job Summary:
We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Boston Scientific. As a key member of our Complaint Management department, you will be responsible for analyzing customer complaints to determine regulatory reportability and coordinating activities with internal, field, and end-use customers.
Key Responsibilities:
- Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
- Participate in the development and modification of decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
- Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
- Collect, compile, and document regulatory reportability decisions using event investigation and regulatory decision models.
- Draft 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.
- Draft written communications detailing the clinical observation, investigation, and/or product analysis, and corrective actions, as applicable, to physician and other end-use customers.
- As applicable, conduct follow-up communications with the Complaint Management Center and R&D representatives.
- Assist in the receipt and processing of returned devices.
- Assist with engineering evaluations. Assist with generation and updates of procedures (engineering changes).
- Give monthly updates of complaints as required per procedures.
- Be in compliance with Feeder System responsibilities as the Complaint Feeder System owner.
- Become a trainer for the software related to complaints handling process (GCS2), as required.
- Responsible to be the backup complaint Subject Matter Expert (SME) ready to be audited at any time.
- Responsible for maintaining the complaint department in compliance with all corporate and applicable regulations related to complaint investigation site.
- Act as supervisor of the Complaints Inspector if required.
- Perform additional duties as assigned.
Requirements:
- Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering, or a related field.
- English Level desired: B1+ (70% - 79%).
- Desired knowledge: Statistical skills, ASQ Certified, knowledge of Six Sigma, knowledge of Lean, APQP, or similar.
- Or an equivalent combination of education and experience.
About Boston Scientific:
At Boston Scientific, 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.
Benefits:
- Life-Work Integration
- Community
- Career Growth
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