Program Manager - Regulatory Compliance and MDR/Ivdr Transition

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Program Manager - Regulatory Compliance and MDR/IVDR Transition

Dienstgeber: Greiner Bio-One GmbH
Arbeitsort: Kremsmünster
Vertragsart: Unbefristet

Your challenge

• Provide leadership and direction to cross functional teams
• Ensure all products are fully compliant with MDR/IVDR regulations by the specified deadlines
• Enhance the company´s overall regulatory compliance framework
• Foster a culture of continous improvement and regulatory awareness within the organisation
• Develop and execute highly comlex project plans to ensure timely completion of all tasks
• Monitor project progress and make necessary adjustments to stay on track
• Comunicate project status, risks, and issues to senior management and other stakeholders
• Identify potential comliance risks and develop mitigation strategies
• Conduct regular regulatory risk assessments and update risk management plans as needed
• Ensure comliance with all relevant regulatory requirements and standards

Your profile

• Master´s degree in business administration, life sciences, or a related field
• 5+years of experience in managing complex, cross functional projects
• Project management professional certification is a plus
• 7+ years of experience in regulatory compliance, preferably in the medical device or in vitro diagnostic industry
• Strong understanding of MDR/IVDR regulations and requirements
• Profiency in English language in reading and writing
• You have strong ethical standards and high level of integrity
• You are driven to achieve high standards and excel in challenging environments

Our offer

We offer you an exciting and independent area of responsibility in a modern and collegial working environment. In addition to numerous attractive social benefits, the gross annual salary for this position is at least EUR 58.200,00 (minimum salary according to the collective agreement for the chemical industry). Depending on your qualifications and professional experience, you may be eligible for a significant overpayment.

If you have any questions or require further information about this job advertisement, please contact Manuela Silbermayr +43 664 8892 0539.

If you are passionate about promoting innovative medical devices and possess the skills and experience outlined above, we encourage you to apply for this exciting opportunity to join our dynamic team at GBO International. Please submit your resume and cover letter detailing your relevant experience and qualifications. We look forward to hearing from you!

Wir stehen als Arbeitgeber für Chancengleichheit und berücksichtigen alle qualifizierten Bewerber:innen unabhängig von Merkmalen wie Geschlecht, Alter, Hintergrund, sozialem Status, sexueller Orientierung, Religion sowie geistigen und körperlichen Fähigkeiten. Wir haben uns das Ziel gesetzt, den Frauenanteil in Führungs- und Expertenfunktionen zu erhöhen und ermutigen daher qualifizierte Frauen sich zu bewerben.

• Aus- & Weiterbildung
• Altersvorsorge
• Betriebsarzt*
• Essenszuschuss
• Gesundheitsmaßnahmen
• Flexible Arbeitszeiten*
• Parkplatz*
• Kinderbetreuung*
• Firmenevents
• Vergünstigungen
• Home Office*
• Variable Vergütung
• Jobrad
• Zusatzversicherung
• Verkehrsmittelzuschuss

 *Standort- und/oder Positionsabhängig

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Are you looking for challenges? Do you thrive in dynamic environments where your proactive mindset and leadership skills can shine? If so, we have the perfect opportunity for you!

We are looking for a highly self-empowered and proactive individual with a strong and thorough understanding of the MDR/IVDR regulatory framework to take the lead in successful MDR/IVDR transition for our products. The ideal candidate will have experience in project management, regulatory affairs, and ideally, previous experience with MDR/IVDR transitions. This is a challenging position that requires a driven and ambitious professional who can steer people and drive highly complex projects to successful completion.

Job ID: 2752
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