Device Project Leader

vor 1 Tag

Basel, Schweiz Sobi Vollzeit

**Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.**

**Device Project Leader**:
**Role & Function**
You are a Medical Device and Combinations Products expert who owns your project, you want to make it a success and ensure that everything required to make it happen is available and/or performed. You like to communicate with other functions, explain needs and also listen to the needs of these. You like to communicate, understand the position of others but also can transport the requirements for your projects and what is required to progress.
At Sobi we are working on a broad range of products with very different indications and ways of administration. This keeps working interesting as you deal with diverse challenges but also requires you to be ready for such an environment. We are looking for an energetic person who prefers challenge rather than uniformity in activities.

**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**
- 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**Personal attributes**
"Make-it-happen"-mentality person with good communication skills, who is able and willing to influence their environment in order to reach their goals and shows some patients and persistence to get there.
In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

**Location**
The position will be based in Basel, Switzerland.

**Reporting to**
Head of Device and Packaging

**Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.

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