Device Project Leader

Job Detail

Job-ID 341209

Job-Beschreibung

Company DescriptionStatistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases.As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.Job DescriptionAt 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.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.

QualificationsYou 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.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

Additional InformationHow to applyAt Sobi, we value work-life balance and due to the holidays, it may take a little bit longer until you hear back from us.We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include your resume in English.Why Join Us?Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:

Emphasis on work/life balance
Collaborative and team-oriented environment
Opportunities for professional growth
Diversity and Inclusion
Competitive compensation for your work
Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

We are a global company with over 1,800 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 CultureAt 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.