Regulatory Affairs & Quality Assurance Manager

Sweden - Stockholm - Full time

Join our growing team of leading scientists, engineers, and professionals committed to the mission of enhancing diagnostic precision to improve cancer treatment decisions and patient outcomes. 

Stratipath is a place for pioneers: for those with a passion for investigating unchartered territories and boldly advancing diagnostics and patient care. 

Role

The RA/QA manager is responsible for regulatory affairs and quality assurance activities for Stratipath. You will manage the daily operations of regulatory affairs and quality assurance in an R&D environment, as well as to ensure that Stratipath’s product complies with the regulations in target markets.

Who you are

We value grit and a can-do attitude; there is a long and challenging journey ahead of us. You are brave enough to set high goals and then work passionately to achieve them. Last, but not least, we think you believe in by working together we will achieve greater things than by working alone.

Areas of responsibilities

  • Develop and maintain Stratipath’s Quality Management System in accordance with regulatory and corporate requirements, such as ISO13485, FDA (21CFR), IVDD/IVDR, CLIA, CAP and other.
  • Lead and participate in Quality Management System processes such as CAPA, NCMR, Document Control, Supplier Quality, Management review processes, Post market surveillance
  • Manage the process of registering and obtaining regulatory approval for new/extension and change of IVD devices. 
  • Write lightweight and easy to understand policies, procedures, and programs, with support from others when necessary and drive the implementation of these policies and procedures to our agile and fast-growing organization.
  • Advocate and communicate the importance of product compliance and train personnel on relevant policies, standards, and processes
  • Plan, track and execute implementation of new frameworks in new markets and make sure nothing falls between the cracks.
  • Review software verification and validation activities to ensure compliance with the regulations and applicable standards
  • Perform internal quality assurance and follow up on implemented policies to make sure they work efficiently

Essential requirements:

  • You have expertise within Regulatory affairs with knowledge of Quality Assurance and Medical Devices and/or In Vitro Diagnostic products across global markets.
  • At least 3-5 years of working experience within an agile R&D organisation, government authority, notified body or corresponding where you worked with quality assurance, regulatory affairs or the development of medical device software.
  • You are familiar with standards such as ISO 13485, ISO 9001, ISO 14002, IEC 62366, IEC 62304.
  • You have a strong sense of ethics and principles but have a pragmatic and in-it-for-the-long-game work attitude where proactive, thorough and a willingness to keep learning are leading words.
  • You have experience working with a diverse set of stakeholders to figure out reasonable ways forward
  • You are highly skilled in reading and synthesising complex regulatory standards into understandable frameworks and policies for the organisation.
  • You must be a good communicator with excellent command of both oral and written English
  • You have sufficient legal understanding such that working together with a legal team is second nature to you.
  • You have excellent organisational skills

Apply:

Please send your CV including a cover letter where you describe why you are interested in this position and why you believe you are a perfect match for Stratipath to careers@stratipath.com.

This website uses cookies. By continuing to use this site, you accept our use of cookies.  Learn more