Regulatory Affairs/Clinical Manager
vor 16 Stunden
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Principal Specialist Consultant at SciPro - Medical Devices & Digital Health across DACHThis position focuses on managing and updating regulatory documentation to ensure compliance with international standards. Key responsibilities include:
Responsibilities:- Designing and executing regulatory strategies that align with organizational objectives.
- Preparing, submitting, and maintaining essential regulatory documents, such as technical files and compliance submissions.
- Partnering with R&D teams to compile and manage technical documentation.
- Serving as the primary contact with regulatory authorities, notified bodies, and other key stakeholders.
- Tracking changes in regulatory guidelines to maintain product compliance with evolving standards.
- Facilitating cross-departmental communication to align product development with regulatory requirements.
- Performing literature reviews and clinical evaluations.
- BSc in Engineering or another scientific field
- 3–4 years of experience in regulatory affairs, with a focus on surgical navigation or robotics.
- In-depth knowledge of EU/US medical device regulations (familiarity with other global standards is a plus).
- Pragmatic, agile approach to work
Mid-Senior level
Employment typeFull-time
Job functionQuality Assurance
IndustriesMedical Equipment Manufacturing
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