Executes PMS activities in accordance with established procedures, processes, and regulatory requirements.
Coordinates the blocking and unblocking of medical devices impacted by Commercial Holds or PFAs in the ERP system, upon request from the Legal Manufacturer.
Ensures the products and the customers impacted by a Commercial Hold or a PFA are properly identified
Initiates and manages product quarantines and releases related to Commercial Holds and PFAs.
Ensures timely and accurate communication of PFAs and Commercial Holds to local business teams and key stakeholders.
Performs final lot reconciliation and proactively resolve discrepancies related to PFAs and Commercial Holds, in collaboration with cross-functional departments.
Manages the end-to-end Product Complaint Handling process for the CEE region, including timely opening, follow-up investigation, and closure of complaints.
Obtains complete and accurate supporting information from customers and internal stakeholders to enable effective product complaint investigations.
Prepares and issues complaint closure letters to customers, where applicable.
Facilitates effective information exchange with Stryker Divisions regarding technical assessments and medical evaluations.
Reports product safety issues and adverse events to competent authorities in compliance with local, regional, and global regulations.
Collects, maintains, and interprets local, national, and CEE PMS and vigilance requirements to support regulatory submissions and ongoing compliance.
Supports the development, deployment, and local implementation of new PMS systems, tools, and procedures.
Identifies gaps or needs for new PMS requirements or procedures and participate in their development and implementation.
Implements and maintains local PMS-related documentation (procedures, work instructions, training materials) in alignment with Corporate and EMEA policies and procedures.
Contributes to continuous improvement initiatives across PMS and RAQA processes at regional and local levels.
Supports PMS process alignment during integration of new acquisitions.
Assists other departments in developing SOPs to ensure post-market regulatory compliance.
Prepares regular PMS and RAQA reports (e.g., weekly, monthly), KPIs, and metrics as requested.
Supports quality management reviews, regulatory inspections, and internal or external audits, including documentation preparation and audit readiness activities.
Delivers training to relevant stakeholders on current and new PMS requirements to ensure organization-wide compliance.
What You Need
BS in Engineering, Science, or related degree; or MS in Regulatory Science
2 years of experience in Regulatory Affairs, Quality Assurance, Post-Market Surveillance, or a related medical device or regulated industry role.
Demonstrated technical and scientific knowledge of medical device regulations and quality system requirements.
Ability to communicate effectively with regulatory authorities and internal and external stakeholders on routine and moderately complex topics, with limited supervision.
Ability to work independently on standard activities and escalate non-routine issues appropriately.
Strong attention to detail, analytical mindset, and process orientation.
Ability to make limited, unreviewed decisions within defined procedures and responsibilities.
Builds effective working relationships across cultures, functions, and geographies within the EMEA organization.
Prepares clear and accurate documentation for regulatory interactions, audits, and management reviews.
Accountable for local implementation of PMS processes and related training.
Capable of preparing and analyzing PMS metrics for reporting and performance monitoring.
Strong IT proficiency, including Microsoft Office applications.