Provides support in the tasks related to Product Registration, Regulatory Affairs & Quality Assurance (including audit processes).
Collaborates in the execution of the processes that guarantee fulfillment of these.
Act in compliance with the Stryker code of conduct, laws, regulations and standards applicable in Argentina & Uruguay.
Ensure that the authorization licenses for Stryker Argentina activities are maintained.
Responsible to ensure document accuracy of information submitted before the Health authority.
Including but not limited to :
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
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.
Academic qualifications / degree & relevant prior experience :
Key strengths / personal attributes for the role :
Academic degree in Pharmacy or student finishing the study programm
5 years of experience in Quality Assurance & Regulatory Affairs.
Advanced English (reading and writing).
Health regulation in force for medical devices.
At least 1 year with active participation in Trade Associations and relationships with Health Authorities.
ISO 9001 / 13485 Internal-Leader Auditor desired.
Experience 2 years at the Medical Devices Industry
Initiative and innovation skills
Ability to adapt to changes and work under pressure.
Excellent communication skills, teamwork, resource management and task resolution.
Good communication capacity.
Health Technology Development.
Work From Home : NoTravel Percentage : None