Device Project Leader
Device Project Leader
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Job Description
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.
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
- Indepth 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 Sobis 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 Makeithappenmentality 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 nontechnical 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 Information :
How to apply
At Sobi we value worklife 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 teamoriented environment
- Opportunities for professional growth
- Diversity and Inclusion
- Competitive compensation for your work
- Making a positive impact to help ultrarare disease patients who are in need of life saving treatments
We are a global company with over 1800 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our daytoday wins and a Board with a stellar track record were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre 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 firsthand 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 groundbreaking 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 cant 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
