* Working within the Product Management department, you will lead and develop a team of Post Market Surveillance experts and specialists delivering product management services, fostering collaboration and building capability.
* Act as the main interface between PMS, Regulatory Affairs, Quality, and Product Management. Communicate PMS findings and recommendations to influence product lifecycle decisions.
* Define and maintain PMS processes ensuring regulatory compliance with global and local regulatory requirements (e.g., MDR,IVDR, FDA).
* Oversee timely completion of PMS documentation, including PMS, PMCF, PMPF, PSUR, and vigilance reports.
* Assess risk relevant for MD and IVDs within scope of all PMS documents.
* Budget responsibility for the PMS team.
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, Familiarity with quality management systems.
* Extensive experience in designing and implementing PMS processes across multiple markets.
* Familiarity with quality management systems (QMS).
* Proven experience in managing cross-functional projects, ideally first exerience of leading teams.
* 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 in Austria 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.
* Generous benefits If you have any questions or require further information about this position, please contact Hannah Shepherd on +43 664 8891 4986.
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.
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