Post Market Surveillance Specialist

What You Will Do

• 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.
• Fluent in English