Regulatory Affairs & Quality Assurance Specialist in Buenos Aires at Stryker Corporation

发布日期: 2/13/2020



Who we want

  • Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.
  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

What will you do

1.- Compliance

  • All business and related matters must be conducted in accordance with all laws and regulations, including the Foreign Corrupt Practices Act (FCPA), the Stryker Code of Conduct, and to the highest ethical standards.

2. Quality Assurance

  • Take the necessary actions for the maintenance and monitoring of the Quality Management System, and its adequacy to the current regulations to be required.
  • Manage Complaints & CAPAs, including contact with Surgical Technicians
  • Analyze data to identify potential nonconformities and improvement opportunities
  • Monitoring and optimization of Service Indicators
  • Define and implement the Internal / External Audit Program. Conduct enabling site visits and monitoring storage conditions of distributors and direct customers, where required
  • Define and Implement the Audit Program for Suppliers and Distributors
  • Align and maintain updated local procedures according to corporate documents.
  • Control of changes
  • Verification, release of products and their traceability.
  • Maintenance and monitoring of databases and process KPIs
  • Maintain and / or achieve the different certifications required by the company
  • Receive, report and track complaints responses generated by product quality, using Stryker tools designed for this purpose (CHS – TrackWise)
  • Follow up, communication and timely report of products involved in quality quarantines (Hold) utilizing applicable Stryker PMS systems
  • Coordinate needed activities for launching, implementation and closing of field safety corrective actions (FSCA) utilizing applicable Stryker PMS systems.
  • Prepare input information required and track the proper QMS management reviews implementation.
  • Define and implement training programs, creating awareness through the organization members on the importance and commitment to the QMS, different QMS processes.
  • Manage and obtain Product Quality Certificates of Analysis issued by the manufacturers where applicable
  • Check the timely and correct identification and disposal of the product returned by customers, quarantine and non-compliant.

3. Regulatory Affairs

  • Responsible for the management of documentation and local coordination for compliance with the annual product registration plan
  • Responsible for taking the regulatory actions related to the renewals, maintenance and updating of the product records according to the notifications of change sent by the manufacturers.
  • Contact with Competent / Co-Responsible Technical Authority (if graduated) before the Health Authority with legal responsability for the imported and distributed products
  • Maintenance and monitoring of databases and KPIs
  • Support to the different areas in specific tasks.
  • Follow up and communicate to commercial teams about regulatory status and registration progress on current and new devices for the Styrker Argentina business.
  • Responsible the following activites:
  • Use of the GPRD process and available Stryker databases to obtaining technical and legal documentation required for the completion of registration dossiers for regulatory filling
  • Prepare and submit answers to the health authority requirements on registration dossiers on process in a timely manner in accordance the regulatory requirements
  • Obtain, prepare, submit and track the product samples when required by regulatory authorities through registration processes.
  • Accurately track and update and maintain databases of registration records and health approval
  • Maintain a registration renewal process in line with regulatory requirements
  • Review and comment on the regulatory impact of device changes and communicated through Stryker Change notification processes
  • Measure and report metrics on regulatory filings submission and approval.
  • Manage the regulatory requirements for local medical devices labeling and partner with the operations and distributors to complete any required local labeling

4. Advocacy

  • Participate in technical committees and trade associations during discussions and public consultations on existing or proposed regulations.
  • Monitor the necessary procedures with the regulatory authorities and Ministries of Health of different countries to obtain regulatory approvals.
  • Prepare and submit answers to the health authority on registration dossiers in process.
  • Prepare, submit and follow up consultations on applicable regulations on company products and processes.
  • Communicate and keep organization and stakeholders informed about possible changes to health regulation and its implications in region´s countries.
  • Maintain and develop a Regulatory intelligence database and be capable to analyze the information available.

What will you need

  • Academic degree in Pharmacy required
  • 5 years of experience in Quality Assurance & Regulatory Affairs and 2 years of experience in RA specific functions required
  • Intermediate English (reading, writing and spoken) required
  • Health regulation in force for medical devices required
  • At least 1 year with active participation in Trade Associations and relationships with Health Authorities.
  • ISO 9001/13485 Internal-Leader Auditor desired.
  • Experience at the Medical Devices Industry required
  • This person will be technical in charge for reports.

Work From Home: Occasional

Travel Percentage: 10%