Medical Device Technical Regulatory Affairs Project

vor 24 Stunden


Allschwil, Schweiz Idorsia Pharmaceuticals Ltd. Vollzeit

**About Idorsia Pharmaceuticals Ltd**

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.
In order to achieve this, we want to develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.
Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet - the ideal constellation to bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,000 highly qualified specialists dedicated to realizing our ambitious targets.

We are looking for an enthusiastic and motivated **Medical Devices Technical Regulatory Affairs Project Manager** to join our team

**Responsibilities**
- Provide technical regulatory expertise for global development of medical devices (e.g. parenteral delivery injection systems) to be used in drug-device combination products,
- Prepare Briefing Books and supportive documentation for Health Authorities/Notified Bodies meetings (pre-IND, pre-NDA, End of Phase II, Scientific Advice meetings) related to the medical device/Combination products,
- Collaborating to and transcribing into regulatory documents the product development reports with emphasis on process risk assessments with regards to Human Factors Engineering and Risk Management
- Lead the team discussion, manage the timelines and prepare the answers to the questions raised by Health Authorities/Notified Bodies following the submission of Medical Device related documentation,
- Contribute to and review the Design History File documentation for medical devices including, but not limited to, design input requirements, technical specifications, design verification, design validation and design transfer
**Requirements**:

- Master's Degree or PhD, ideally in engineering or a life-science discipline (Pharmacy, Chemistry, Biology)
- At least 5 years of regulatory experience in device documentation writing, device development of parenteral delivery systems and/or drug/device combination products with main focus on medical devices for parenteral administration.
- Expert knowledge of legislation related to medical devices and combination products (FDA 21CFR 820, EC Directives 93/42/CE and Regulation 2017/745/EU, ISO13485 and ISO14971 standards)
- Expert knowledge of medical devices and combination products development reports with emphasis on process risk assessments with regards to Human Factors Engineering and Risk Management.
- General understanding of pharmaceutical development, clinical trial processes and requirements is preferable
- Good spoken and excellent written English Knowledge of any other European language would be an advantage,
- Good organizational and communication skills and ability to manage complex projects and prioritize workload according to the project importance
- Excellent MS Office skills
**What Idorsia offers**
- Exciting opportunities for development and professional growth within our dynamic organization
- A collaborative and solution-oriented environment where you can make a difference
- An innovative and open culture in a truly multicultural environment
- A competitive salary and generous benefits
**Work Location**:Basel Area - Allschwil
**Country**: Switzerland
**Business Area**: Pharmaceutical Development - Technical Regulatory Affairs
**Schedule**:Fulltime

**Job Type**: Permanent
**Job ID**: 3252

**Job Types**: Full-time, Permanent



  • Allschwil, Schweiz Ultragenyx Pharmaceutical Inc. Vollzeit

    **Why Join Us?** - Be a hero for our rare disease patients_ - _ Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and...


  • Allschwil, Schweiz Hobson Prior Vollzeit

    Hobson Prior are looking for a Scientific Associate Medical Device and Combination Products to join a brilliant biotech corporation on a contract basis located in Allschwil. Our client is focused on finding, inventing and commercialising novel remedies. Please note that to be considered for this role you must have the right to work in this location. **Key...


  • Allschwil, Schweiz Basilea Pharmaceutica International Vollzeit

    **We are looking for...**: ...a highly motivated **Global** **Medical Affairs Scientist / Manager** for our **Global Affairs** department **Your tasks**: - Establish, implement and coordinate the Global Medical Affairs Plan for assigned products and working closely with medical affairs of Commercial partners. The plan includes activities as launch support,...


  • Allschwil, Schweiz Ultragenyx Pharmaceutical Inc. Vollzeit

    **Why Join Us?** - Be a hero for our rare disease patients_ - _ Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and...


  • Allschwil, Schweiz Johnson & Johnson Family of Companies Vollzeit

    **"Caring for the worldone person at a time”**inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion...

  • Functional Manager

    vor 7 Monaten


    Allschwil, Schweiz Johnson & Johnson Vollzeit

    **Functional Manager **(Medical Affairs Delivery Unit **) Johnson & Johnson Innovative Medicine is recruiting for a Functional Manager **(Medical Affairs Delivery Unit **) to be located in the US (Horsham, PA; La Jolla, CA; Raritan, NJ; Spring House, PA; Titusville, NJ), Europe (Basel, CH; Beerse BE; High Wycombe, UK; Cork, IE; Leiden, NL), or Asia (China,...


  • Allschwil, Schweiz SKAN AG Vollzeit

    Founded in 1968, **SKAN** is a pioneer in cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, tailor-made solutions and an effective service organisation have made SKAN a market leader and a key partner to industry and research laboratories. Overview **Responsibilities**: - Independent management of...


  • Allschwil, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson Global Services, the global shared services organization supporting the businesses of Johnson & Johnson, performs select functional work in a consistent manner across regions and sectors using simplified, standardized end-to-end processes and state-of-the-art technology. The vision of Johnson & Johnson Global Services is “to be trusted...


  • Allschwil, Schweiz Johnson & Johnson Vollzeit

    Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a **Clinical Project Physician - Pulmonary Hypertension **to be located in **Allschwil, Switzerland or Raritan, NJ **. At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy...


  • Allschwil, Schweiz Thermo Fisher Scientific Vollzeit

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Project Manager

    vor 2 Monaten


    Allschwil, Schweiz Basilea Pharmaceutica International Vollzeit

    **We are looking for...**: ....a highly motivated **Project Manager** for our **Global Affairs** department **Your tasks**: - Responsibility, management and coordination of activities related to antibacterial and antifungal drug development programs supported by US Government Biomedical Advanced Research and Development Authority (BARDA) - Coordination of...


  • Allschwil, Schweiz Johnson & Johnson Vollzeit

    The Associate Director provides lead support for the design, execution, analysis, interpretation, and reporting or communication of data evidence for Pre/Early/Late Development, Research & Discovery, Medical Affairs, Real World Evidence, or Manufacturing Sciences programs for research, development, and/or marketed product needs in Janssen. This position...


  • Allschwil, Schweiz ThermoFisher Vollzeit

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionKey Responsibilities:Independently manages a client portfolio of moderate to strategic or complex projectsLeads the delivery of all technical and service aspects of projects and studies for clients, looking for opportunities to create better efficiencies or creative problem solving...


  • Allschwil, Schweiz Thermo Fisher Scientific Vollzeit

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Key Responsibilities**: - Independently manages a client portfolio of moderate to strategic or complex projects - Leads the delivery of all technical and service aspects of projects and studies for clients, looking for opportunities to create better efficiencies or creative...


  • Allschwil, Schweiz Thermo Fisher Scientific Vollzeit

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Your Role in that Mission**: **Join our Distributed Client Services team and be part of a united effort: Empowered to Take Initiative, Foster Connections and Deliver Results for our customers and their patients.** The Distribution Project Manager independently manages a portfolio...


  • Allschwil, Schweiz Johnson & Johnson Vollzeit

    Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Project Management Leader, located in Raritan NJ; Titusville, NJ; Spring House, PA; Chesterbrook, PA; Beerse, Belgium; Leiden, Netherlands, or Allschwil, Switzerland. Janssen R&D discovers and develops innovative medical solutions to address...

  • Sr Project Manager

    vor 7 Monaten


    Allschwil, Schweiz Thermo Fisher Scientific Vollzeit

    When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. We are looking for a **Sr Project Manager **onsite in...


  • Allschwil, Schweiz ThermoFisher Vollzeit

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionYour Role in that Mission:Join our Distributed Client Services team and be part of a united effort: Empowered to Take Initiative, Foster Connections and Deliver Results for our customers and their patients.The Distribution Project Manager independently manages a portfolio of moderate...


  • Allschwil, Basel-Land, Schweiz ThermoFisher Vollzeit

    Role OverviewThermo Fisher Scientific is seeking a seasoned Sr. Enterprise Project Manager to lead complex client projects and drive business growth.Key Responsibilities:Lead large, multi-project portfolios, collaborating with cross-functional teams to ensure timely delivery and high-quality results.Maintain strong relationships with clients, providing...

  • Sr Project Manager

    vor 7 Monaten


    Allschwil, Schweiz Thermo Fisher Scientific Vollzeit

    When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. We are looking for a **Sr Project Manager **onsite in...