Regulatory Affairs Associate: Clinical & Compliance

Arkray Group; Plano (TX); On-site; USD 50,000 - 70,000; Full time

Job summary

Arkray Group in Plano, Texas is seeking a Junior or Assistant in Sales Support within the Regulatory Team. This full-time role involves providing support for clinical studies, ensuring compliance, and performing evaluations of products. The ideal candidate holds a Bachelor's degree and has 3–5 years of experience in the medical laboratory or medical device industry, specifically with urinalysis instruments.

Responsibilities include training clinical staff, supporting regulatory submissions, and participating in quality assurance activities. Travel is required for site visits.

Qualifications

• 3–5 years of experience in a medical laboratory or medical device industry.
• Experience with urinalysis IVD instruments and manual microscopy.
• Ability to travel domestically and internationally.

Responsibilities

• Provide hands-on support for clinical studies and training.
• Travel to clinical study sites for training and support.
• Ensure compliance with scientific work and standards.
• Review complaint investigation results related to products.
• Act as Principal Investigator for in-house clinical studies.
• Support evaluation of diagnostic systems and data integrity.
• Participate in regulatory activities such as FDA submissions.

Skills

Clinical study management

Urinalysis product use

Microsoft Office proficiency

Education

Bachelor's degree in Biology, Biochemistry, Chemistry, or related discipline

Tools

IVD instruments

Microsoft Office

Job description

Arkray Group in Plano, Texas is seeking a Junior or Assistant in Sales Support within the Regulatory Team. This full-time role involves providing support for clinical studies, ensuring compliance, and performing evaluations of products. The ideal candidate holds a Bachelor's degree and has 3–5 years of experience in the medical laboratory or medical device industry, specifically with urinalysis instruments.

Responsibilities include training clinical staff, supporting regulatory submissions, and participating in quality assurance activities. Travel is required for site visits.