Senior Regulatory Engineer (HU)
Our goal is to improve the lives of thousands of patients through our transplantation diagnostics tests. This is what inspires us.
The Senior Regulatory Engineer focuses on IVD medical device quality assurance. The incumbent will report to the Chief Technical Officer and work closely with other departments as well.
Responsibilities:
General Regulatory Management
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- Managing IVD medical device feasibility based on the regulation of targeted markets
- Partnering with key stakeholders for the creation of the regulatory strategy and roadmap
- Establishing and maintaining the regulatory profile for IVD medical devices
- Ensuring that regulatory requirements for IVD medical devices are specified and kept up to date
- Establishing and maintaining the technical documentation
- Managing the regulatory approval process of IVD medical devices
Product Regulatory Expert
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- Acting as Product Regulatory Expert for assigned product families, including product regulatory planning
- Acting as Person Responsible for Regulatory Compliance (PRRC) according to Article 15 of Regulation 2017/746 (IVD-R), including but not limited to:
- Establishing and maintaining the Technical File/Documentation
- Establishing and maintaining the Declaration of Conformity (DoC)
- Ensuring that Post-Market Surveillance (PMS) obligations are complied
- Ensuring the issuing of the PEO statement for performance studies
- Managing and monitoring of Performance Evaluation (incl PMPF) activities
Partnering with Quality Management and Research and Development
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- Monitoring of standards and guidance documents related to IVD medical device regulatory profiles
- Partnering to identify gaps within and to improve processes and procedures
- Supervising the documentation of processes related to regulatory compliance
- Monitoring product and process performance and reporting to key stakeholders
- Other duties as assigned
Required Qualifications and Skills:
- MSc in Life Science
- Minimum 3 years of quality and regulatory experience in the medical device field (or similar: pharma)
- Experience with ISO 13485, CE marking, FDA approval
- Self-motivated, works well with minimal supervision
- Strong analytical skills and knowledge of statistical methods
- Sound problem-solving skills
- Advanced English
Advantageous skills
- Experience in the fields of molecular biology, genetics, immunology
- Experience with clinical studies
What we offer you:
- Performance-related annual bonus
- Cafeteria with optional elements (gross 45.000. HUF per month)
- Laptop and mobile phone
- Free coffee and beverages
- Free Parking
- Pleasant office and family atmosphere
- Challenging and innovative work
- We care about your work-life balance
- Company events
Start Date: March 2024
Type of Position: Full-time
Base Location: H-1117 Budapest, Kaposvár utca 14-18.
Sounds just like you?
If you are keen on joining this exciting, forward-thinking company and taking the next step in your career, then please send us your CV in English with your gross salary expectation and possible start date to jobs@omixon.com.
