Device Project Leader

vor 1 Tag

Basel, Schweiz Sobi Vollzeit

**Device Project Leader**

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.

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.

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.

**Why Join Us?**

We are a global company with around 1,500 employees in more than 30 countries, and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

**Sobi Culture**

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them.

This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain.

Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

**An Equal Opportunity Employer**

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