Senior Medical device documentation Associate
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
Medical device documentation- Diagnostic Imaging and Interventional Radiology
- Knowledge of contrast media injectors and disposables in medical imaging (MRI/CT)
- Experience in dossier preparation compilation and submission for medical devices based on the legal manufacturer/physical manufacturer elements and the technical documentation
- Good understanding- of the medical imaging devices compliance from a global and regional perspective registration procedures preparation of answers to questions from health authorities
- Identification of regulatory risks and impact
- Experience in identifying label specific requirements and appropriate process and/or relabeling
- Expertise with regulatory management system and document management systems
- Effective communication and collaboration skills and the ability to work independently
Required Experience:
Senior IC
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
