Device Project Leader
Device Project Leader
Sobi
Basel, Switzerland
As Medical Device and Combinations Products expert you own your assigned projects, are responsible for the projects progress and ensures that everything required to make it happen is available and/or performed. You communicate with other functions, explains the needs for the combination product development and also listens to their needs.
Key Responsibilities
- In-depth knowledge of the regulatory requirements for medical devices and combination products;
- Knowledge and experience in writing DHF/Technical File documents for submissions in EU, US and rest of world;
- Prepare documentation and answer to questions from Notified Bodies as well as Health Authorities and explain Sobi's position during audits;
- Evaluate existing Technical Documentation for marketed products and drive remediation projects when necessary;
- Communicate with Stakeholders from different functions within the organization;
- Ensure efficient information flow and project progress.
Qualifications
You have a “Make-it-happen"-mentality with good communication skills, who is able and willing to influence your environment in order to reach your goals and shows patience and persistence to get there. You have the skill to put yourself into non-technical functions and easily communicate with them.
- 5+ years of experience in Device and combination product project management;
- Experience in working in regulated environment (preferably pharma company);
- Degree in engineering, pharmaceutics or similar;
- Proficiency in English, additional languages are welcome.
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