Associate Manager, RAQA

Stryker Corporation (Buenos Aires, Argentina) Publicado hace 27 días

What We Want

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
  • Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management, and leadership teams.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What You Will Do

Implement and maintain Quality Assurance Systems (QMS) and activities within local regulatory guidelines. Ensures regulatory compliance related to Certifications, Registrations, Complaints, Recalls/PFA, as required by Regulatory Agencies.

Critical factors for Success / Main Products:


Compliance:

  • Must conduct all businesses and affairs in compliance with the laws and the regulations, including with the Foreign Corrupt Practices Act (FCPA) and the Stryker Code of Conduct, in compliance with the highest ethical values.

Regulatory Affairs:

  • Responsible for developing, modifying, and executing regulatory guidelines related to the company and procedures.
  • Maintain current and new products registered according to local regulatory policies.
  • Ensure International Change Notifications are received, and answered accordingly
  • Ensure current Registrations processes are updated, following International Changes Notifications received
  • Ensure alignment with Marketing and Operations team, in order to keep registration strategy and align best operational practices to have products available for commercialization.
  • Ensure RA Executive Summary Communication, through KPIs availability

Quality Assurance:

  • Supports the International recall/PFA process and reports appropriately to the local Authorities.
  • Ensure appropriate communication and treatment of failures associated with Product Complaints to Stryker selling divisions and local Authorities.
  • Service Complaints handling in a direct sales business model (mainly, surgeries) and NC/CAPA management.
  • Maintain and control of the local document management system.
  • Support and guidance to the organization (specially to sales team) to comply all local QMS procedures.
  • Ensure that suppliers (OEMs and services) comply with Corporate and local requirements.
  • Ensure RAQA Executive Summary Communication, through Management Review Meetings.
  • Leads internal audits and communicates the results to the management.
  • Develop and maintain Quality Agreements with designed divisions.
  • Supports International Stryker Legal Manufacturers audits, providing current documentation related to QMS required, and respond questions to Leader Auditor related to Country activities.
  • Supports Indirect Channels qualification program, acting as a Partner with Local IC Manager, Compliance and Finance.

Technical/Tecnovigilance Responsible:

  • Ensure regulatory compliance related to PMS (Post Market Surveillance) activities.
  • Ensure regulatory compliance focused on QMS (Quality Management System).
  • Represents the Company at Sanitary Agencies.
  • Active participation into local trade association (CADIEM).

What You Will Need

  • Bachelor’s degree in Engineering, Biomedical or similar.
  • Skill with the Microsoft Office tool.
  • Knowledge of ISO 14845 and 9001 is preferred.
  • Ability to work effectively in a matrix organization structure with significant emphasis on collaboration and persuasion, rather than relying entirely on command and control.
  • Strong communication skills with ability to communicate effectively with both divisional leaders and technical teams.
  • Strong analytical and problem-solving skills.
  • Good business acumen and negotiation skills.
  • Strong analytical and organizational skills.
  • Driven to continually build knowledge and skills.
  • Able to build trusting relationships in and outside of the organization.
  • Versatility, flexibility, and a willingness to work within dynamically changing priorities with enthusiasm.
  • Advanced English is required.

#LI-LATAM


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