Program Manager - Regulatory Compliance and MDR/IVDR Transition
Program Manager - Regulatory Compliance and MDR/IVDR Transition
Kremsmünster, AT, 4550
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 continuous improvement and regulatory awareness within the organization
- Develop and execute highly complex project plans to ensure timely completion of all tasks
- Monitor project progress and make necessary adjustments to stay on track
- Communicate project status, risks and issues to senior management and other stakeholders
- Identify potential compliance risks and develop mitigation strategies
- Conduct regular regulatory risk assessments and update risk management plans as needed
- Ensure compliance with all relevant regulatory requirements and standards
Your profile
- Master´s degree in business administration, life science 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
- Proficiency 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!