Regulatory & Clinical Affairs Associate

hace 7 días

Barcelona, Barcelona, España Flomics A tiempo completo

Regulatory and Clinical Affairs Associate

Flomics is a biotech company founded in 2018, focused on the development of a
revolutionary multicancer screening solution through liquid biopsy. We combine
Next-Generation Sequencing (NGS), RNA-based biomarkers, machine learning and
sophisticated bioinformatics, to allow the early detection of multiple types of cancers
before the first symptoms appear. Everything from a single blood sample.

We're looking for a talented and motivated regulatory affairs associate to join our team
As a regulatory affairs associate you will be responsible for the day-to-day
implementation and monitoring regulatory and certification activities to ensure
compliance with all relevant regulations. Initially the main focus will be on the definition
of the regulatory roadmap and implementation of key ISO standards.

You should have:

  • Degree in a scientific field such as biotechnology, biochemistry, chemistry, or
molecular biology

  • Minimum 3 years of experience in a similar role
  • Excellent organizational and project management skills
  • Entrepreneurial soul, proactive attitude
  • Wellstructured and pragmatic approach to problem solving, handson mentality
  • English fluency, spanish would be a plus

Your responsibilities
Lead regulatory and clinical department of Flomics- Define regulatory and certification strategy & roadmap of the company,
- including preparation for coming clinical trials
  • Develop and implement the regulatory strategy, drive submissions and
- meetings with regulatory agencies
  • Prepare clinical development plans which integrate clinical, regulatory, market
- access and commercial strategies
  • Define and implement key ISO standards, such as ISO27001, ISO15189 and


 ISO13485
  • Manage and monitor other regulatory matters such as GDPR and PRL
  • Prepare and maintain regulatory documentation reports and databases
  • Participate in the development and implementation of new processes, SOPs etc

What we offer:

  • Fulltime position
  • Salary according to experience and seniority
  • Company phantom shares and other benefits
  • Possibility for remote working and flexible schedule
  • A challenging and motivating environment with high growth possibilities and
continuous learning.

April Flomics Biotech

Required information and contact:

If you are interested in joining our team and working to achieve something

April Flomics Biotech

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