AliveDx

Associate Degree in Clinical Laboratory Science or equivalent, Laboratory experience, Demonstrated Customer Service or Sales Support experience

Relevant education, proven sales success, strategic account management experience, and proficiency in CRM systems

Risk Management or Quality Systems/Engineering qualifications/training. Science degree or equivalent qualification, or a relevant degree combined with appropriate industry experience. Strong understanding of QMS processes, i.e. Customer Complaints, CAPA, change management

2-3 years of experience in a document control or quality assurance role within an ISO 13485 GMP or 21CFR part 820 -compliant environment, preferably in the medical device or pharmaceutical industry

Previous experience of IVDR implementation plans and requirements, Experience of preparing and submitting regulatory applications in geographies outwith EU, US, Canada

Minimum 8 years of experience in a similar role, excellent AD configuration skills, and strong troubleshooting skills

High school degree, experience in GMP Laboratory environment, and proficiency in Microsoft Office

Relevant degree/experience in a regulatory affairs role. Experience in medical device/IVD/Biotech industry. Strong attention to detail and communication skills

Relevant degree, experience with laboratory techniques, good communication skills, and detail-oriented with a collaborative mindset

Science degree, relevant experience, and data analysis skills required