Device Project Leader

vor 2 Wochen

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.

  • Device Project Leader

    vor 2 Wochen

    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...

  • Device Project Leader

    vor 2 Stunden

    Basel, Basel-Stadt, 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 &...

  • Device Project Leader

    vor 2 Wochen

    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...

  • Device Project Leader

    Vor 7 Tagen

    Basel, Schweiz Sobi Vollzeit

    **Role & Function** You are a Project manager 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 listens to the needs of others. You like to communicate, understand the position of others but also can...

  • Device Engineer

    vor 3 Wochen

    Basel, Schweiz Roche Vollzeit

    The Position The Device Development Department within Roche Technical Development is responsible for the development and support of drug delivery devices for the product portfolio. Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support. Roche is...

  • Device Engineer

    vor 2 Wochen

    Basel, Schweiz Roche Vollzeit

    The Position The Device Development Department within Roche Technical Development is responsible for the development and support of drug delivery devices for the product portfolio. Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support. Roche is...

  • Quality Project Lead

    vor 1 Woche

    Basel, Schweiz Datalynx AG Vollzeit

    For one of our clients in Basel, we are currently looking for a Quality Project Lead (M/F/d). **Background** Execution of defined actions from the Sandoz Separation planning under the responsibility of TRD QA Medical Devices. Backfill of capacity for general activities to allow the personnel to dedicate expertise and management engagement for all demands...

  • Project Manager Biopharma Switzerland

    vor 2 Wochen

    Basel, Schweiz IPS-Integrated Project Services Vollzeit

    Position Responsibilities: Our business in Switzerland continues to grow! We, IPS Integrated Project Services, are a US-headquartered global leader in the leadership and execution of advanced facilities engineering and design. Globally represented in 17 countries, with 45 offices and 3000+ professionals worldwide, IPS provides technical consulting,...

  • Director - Device and Formulation Development (Jh)

    vor 2 Monaten

    Basel, Schweiz Vectura Vollzeit

    About the role: As Director - Device and Formulation Development, you will work closely with the Scientific Innovation leadership and play a pivotal role in the development and success of our Innovation Centre in this dynamic and quickly evolving market. - This is a real opportunity to play a central role in ensuring the continuation and ongoing development...

  • Clinical Trial Leader

    vor 3 Stunden

    Basel, Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    Clinical Trial LeaderFor our medical device partner in Basel, we are looking for an experienced Clinical Trial Leader who will be responsible for overseeing international medical device studies.Responsibilities Managing and developing clinical project plans to identify and complete clinical trial milestones. Managing and providing accountability for daytoday...

  • Medical Device Validation Consultant

    vor 2 Wochen

    Basel, Schweiz wega Informatik Vollzeit

    We are a Pharma and Life Science IT service provider that has been successfully carrying out 'state-of-the-art' projects for international customers for 30 years, now. Our consultants work in - our office in Basel - from home - on our customer’s premises We are a dynamic forward-thinking and expanding organization with a great team spirit and always on...

  • Office & Project Administration Assistant

    Vor 5 Tagen

    Basel, Schweiz IPS-Integrated Project Services Vollzeit

    Position Responsibilities: Our business in Switzerland continues to grow! We, IPS Integrated Project Services, are a US-headquartered global leader in the leadership and execution of advanced facilities engineering and design. Represented in 17 countries, with 45 offices and 3000+ professionals worldwide, IPS provides technical consulting, architecture,...

  • Drug Product Project Leader

    vor 1 Woche

    Basel, Schweiz Novartis Vollzeit

    389788BR **Drug Product Project Leader (Oligonucleotides) (M/F/d)**: Switzerland **About the role** Location: Basel, Switzerland Join us in a cutting-edge role as a Drug Product Project Leader (DPPL) for Oligonucleotides, where you will have the opportunity to work on innovative parenteral formulations and contribute to the development of patient-centric...

  • Electrical Engineer BioPharma Projects

    vor 3 Wochen

    Basel, Schweiz Integrated Project Services Vollzeit

    Job Description IPS is hiring! Global leader in Engineering is looking to hire a passionate and talented Electrical Engineer to join our growing Swiss team in Basel! At IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people, solving complex technical challenges related to projects within the life sciences...

  • Clinical Trial Leader

    vor 2 Monaten

    Basel, Schweiz Coopers Group AG Vollzeit

    **Clinical Trial Leader** For our medical device partner in Basel, we are looking for an experienced Clinical Trial Leader who will be responsible for overseeing international medical device studies. **Responsibilities** - Managing and developing clinical project plans to identify and complete clinical trial milestones. - Managing and providing...

  • Technical Project Leader Drug Product- Parenteral

    vor 2 Wochen

    Basel, Schweiz ALTOGEN AG Vollzeit

    **ALTOGEN** is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to expert...

  • Project Procurement Lead

    vor 2 Monaten

    Basel, Schweiz ALTOGEN AG Vollzeit

    **COMPANY** ALTOGEN is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise, and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to...

  • Project Procurement Lead

    vor 2 Wochen

    Basel, Schweiz ALTOGEN AG Vollzeit

    **COMPANY** ALTOGEN is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise, and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to...

  • Director of Research and Development

    vor 1 Monat

    Basel, Schweiz BioTalent Ltd Vollzeit

    Job Description: Director of Research and Development (Medical Devices) Overview: We are currently seeking a highly skilled and experienced Director of Research and Development to head our R&D department, specializing in the innovation of advanced medical devices. The successful candidate will possess an extensive background in medical device engineering, a...

  • Director of Research and Development

    vor 2 Wochen

    Basel, Schweiz BioTalent Ltd Vollzeit

    Job Description: Director of Research and Development (Medical Devices) Overview: We are currently seeking a highly skilled and experienced Director of Research and Development to head our R&D department, specializing in the innovation of advanced medical devices. The successful candidate will possess an extensive background in medical device engineering, a...