Regulatory Affairs / Quality Management Specialist
About Scailyte
Scailyte’s mission is to discover and develop biomarkers for precision medicine using single-cell data and Artificial Intelligence. Our pioneering technology integrates multimodal single-cell and clinical data to identify novel disease signatures. We are providing innovative solutions for rapid discovery of ultra-sensitive biomarkers for customers in pharma, biotech and clinical research. We are a multidisciplinary multinational team of highly skilled and enthusiastic professionals, offering an inspiring and open-minded environment for career growth. Check out our company video and what our employees say about working at Scailyte: Scailyte Youtube channel
About the role:
We are currently developing a first-in-class in vitro diagnostic tool for Endometriosis aiming at cutting the time to diagnosis by years and improve the quality of life of millions of women. We look to strengthen our team with a Regulatory Affairs / Quality Management Specialist, passionate about making a change for patients, eager to learn and grow professionally, and dedicated to delivering top quality results.
Key responsibilities:
- Design, implement, maintain and continuously improve our Quality Management System
- Audit our internal processes and technical files to ensure compliance to internal and external regulations and standards
- Contribute to building technical documentation and design dossiers, which we will use for CE marking and FDA approval processes (focus on FDA)
- Monitoring of quality and regulatory aspects
- Train the team to follow the procedures and answer questions of the team regarding QA aspects
- Communicate, track, audit and report progress company-wide and to the relevant stakeholders
Required Skills and Competences:
- A technical or life sciences degree
- Minimum 2 years of relevant experience in medical devices RA/QA/QM functions
- Good understanding of medical devices quality assurance and regulatory environment (ISO:13485 and MDSAP) and relevant standards.
- Keen for self-development and company’s growth
- Initiative, autonomous and flexible
- Excellent communication and organizational skills
- Fluency in English is a must, additional knowledge of German or French are an advantage
Additional requirements:
- Valid Swiss work permit (or EU/ Swiss citizens)
- Potential starting date: 1st April 2022 or earlier
Why join Scailyte?
At Scailyte, we dream big and pioneer solutions that benefit patients. We offer an innovative, fast-paced and dynamic working environment. We are based at the heart of the two major biotech ecosystems: Basel & Boston (the current position is initially Basel-based, with the possibility for relocation to Boston in 2023). We offer attractive compensation plans with participation in Scailyte’s equity and value growth, a permanent employment contract and career development programs.
Application
To apply, please email your cover letter, your CV (in English) and contact addresses of at least two professional referees as PDF to careers@scailyte.com.
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VACANCY: Regulatory Affairs / Quality Management Specialist
We are currently developing a first-in-class in vitro diagnostic tool for Endometriosis aiming at cu
Scailyte Webinar - Why single-cell technologies are vital for Endometriosis research
Prof. Dr Michael D. Mueller is an expert in endometriosis and women’s health. The complexity of th
Recent News
Single-Cell Discovery Grant in Oncology and Immunology
Open grant call of up to 100K Euro aimed at addressing unmet clinical needs in Oncology and Immunolo
Scailyte and Lexogen create a joint biomarker discovery workflow for precision medicine companies
Scailyte, a single-cell biomarker discovery company and Lexogen, a leader in RNA sequencing solution
Recent News
Scailyte Quarterly Update, June 2021
Quarterly update on Scailyte's progress towards its mission to save millions of lives.
Scailyte announces Michael Brenner, of Harvard Medical School, as an advisor to its Board of Directors
Artificial Intelligence (AI)-driven biomarker discovery innovator Scailyte announced today that Mich
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Scailyte Quarterly Update, April 2021
Quarterly update on Scailyte's progress towards its mission to save millions of lives.