Expert Post Market Surveillance (all genders)

Expert Post Market Surveillance (all genders)

Company: Greiner Bio-One GmbH
Location: Kremsmünster
Employment Type: Permanent

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 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.

We provide equal opportunities for everyone and see diversity as our strength. Therefore, we welcome all applicants - regardless of characteristics such as gender, age, background, social status, sexual orientation, religion, or mental and physical abilities. We have set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.

• Training and Further Development
• Pension Fund
• Company doctor*
• Lunch Allowance
• Health Measures
• Flexible Working Hours*
• Parking*
• Childcare Services*
• Company Events
• Discounts
• Variable Compensation*
• Home Office*
• Supplementary Insurances
• Job bike
• Transportation Allowance

 *Depending on location and/or position

Apply now »

About Greiner Bio-One

Greiner Bio-One feels like home.

For visionaries with drive and ideas, for team players who share their knowledge and entertain new ways of thinking, for people whostrive for excellence. Our door is always open to achievers, doers and hidden talents who want to make a difference.

We have future in our blood.

Job ID: 3740
Apply now »