QA RA Specialist (manual)

Location: Remote in the US.

Type: Full-time, permanent

Visa Sponsorship: Unfortunately, we are not in the position to offer visa sponsorship for this role.

We are seeking a QA/RA Specialist, Clinical, North America to join our Diagnexia team in the US. This is a key role within the QA/RA Clinical group, responsible for ensuring that clinical laboratory operations, products and services across Diagnexia US and Diagnexia Canada meet the highest quality and regulatory standards. The successful candidate will bring combined expertise in quality assurance and regulatory affairs, acting as a single point of accountability for QA/RA matters across our North American clinical operations.

Quality Assurance

Regulatory Affairs

General

• Bachelor's degree or higher in Life Sciences, Clinical Laboratory Science, Computer Science or a related field
• At least 5 years' experience in a quality assurance and/or regulatory affairs role within a regulated life science, clinical services or medical device environment
• Strong knowledge of US laboratory regulations, including CLIA 42 CFR 493 and CAP General Laboratory, Anatomic Pathology and proficiency testing requirements
• Working knowledge of FDA regulations applicable to clinical digital pathology, including 21 CFR 820
• Excellent communication, collaboration and stakeholder management skills, including technical report writing
• Strong analytical and problem-solving skills, with the ability to work independently and manage multiple priorities and deadlines
• Experience managing a CAP laboratory accreditation programme, or certification/professional training in CLIA/CAP laboratory accreditation or regulatory affairs
• Experience with Software as a Medical Device (SaMD) and medical device regulation
• Experience with US and Canadian regulatory frameworks for SaaS products and clinical services
• Experience with digital pathology scanning equipment and software systems, AI technologies and emerging AI standards, and/or pathologist licensing and credentialing
• Experience with laboratory billing practices, Stark Law, anti-kickback and anti-markup rules
• Experience with recognised quality management systems or standards such as ISO 13485, ISO 15189:2022 or equivalent

Through the work that we do, the team at Deciphex helps pharma to accelerate the process of essential drug development and helps patients to get timely and accurate diagnosis.

Founded in Dublin in 2017, Deciphex has scaled rapidly to a team of over 230 people and counting who are providing software solutions to address the pathology gap in research pathology and clinical areas. We have offices in Dublin, Exeter, Oxford, Toronto and Chicago and are expanding our team throughout the world.

We are software developers, clinical specialists, AI engineers, operations professionals and so much more, all working as one team to support our customers and patients. Our team culture is built on trust. We give our team the space they need to deliver results and the environment to ensure they can enjoy doing it.

We are looking for highly motivated individuals who are excited to take on challenges and value making a difference in their day-to-day work. This is a unique opportunity to make a difference in the emerging Digital Pathology field.

Read more about Deciphex here and more about our incredible team on our Careers Page here

Deciphex is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race, religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the travelling community or any other classification protected by applicable law.

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