Medical Device Technical Regulatory Affairs Project
vor 24 Stunden
**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
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