Expert Post Market Surveillance (all genders)
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Your challenge
* Collect and analyze post-market data (complaints, adverse events, customer feedback, service reports) to identify trends and potential risks.
* Review all relevant literature and other scientific information
* Ensure regulatory compliance with global and local post-market surveillance requirements (e.g., MDR, IVDR, FDA).
* Drive & develop timely preparation of PMS documentation, including PMS, PMCF, PMPF, PSUR, and vigilance reports.
* Assess risk relevant for MD and IVDs within scope of all PMS documents
* Drive continuous improvement by recommending design or process changes based on surveillance insights.
* Support audits and inspections by providing PMS evidence and ensuring readiness.
* Act as subject matter expert for PMS processes and tools, providing guidance and training to internal teams.
Your Profile
* Higher education degree in healthcare, life sciences or business administration with profound professional experience in regulatory compliance for MDR and IVDR.
* Strong understanding of risk management and vigilance reporting, ideally familiarity with quality management systems.
* Experience in designing and implementing PMS processes across multiple markets.
* Proven ability to influence and guide cross-functional teams effectively.
* High level of proactivity, flexibility and teamwork orientation.
* Excellent written and verbal communication skills in English (C2 preferred), German highly beneficial.
Our Offer
* Extensive career and development opportunities
* 38.0-hour week, flexitime
* The gross annual salary for this position is at least EUR 59,781.96 (minimum salary for the chemical industry). Depending on your qualifications and professional experience, we are willing to pay above the minimum.
* Numerous benefits
If you have any questions or require further information about this position, please contact Hannah Shepherd on +43 664 8891 4986. Please be aware that we will be out of the office until January 7th 2026 due to the Christmas holiday season.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Product Management
Industries
Plastics Manufacturing
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