- Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
- Participate in development and modification of these 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 transmition to the appropriate regulatory authorities. Draft Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmition 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. Communications include determination/eligibility for warranty credit or unreimbursed medical payments.
- As applicable conduct follow-up communications with 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 with 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.
- Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or 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.
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IT Business Analyst
hace 3 días
Boston Scientific Coyol, Costa RicaAdditional Locations: Costa Rica-Coyol · Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance · 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 ...
Analyst I, Product - Coyol, Costa Rica - Boston Scientific
Descripción
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
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 and has been recognized with the Catalyst Award in 2022, a prestigious recognition of diversity, equity and inclusion excellence. Also, we have a Gender Equality Policy to support our commitment.
Hybrid Roles:
Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview.
About the Role:
Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.
Your Responsibilities Include:
What We're Looking For:
Requisition ID: 582167
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
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.