Senior Software Compliance & Design Assurance

Meridian Bioscience International Limited; United States; Remote; USD 80,000 - 110,000; Full time

Job summary

Meridian Bioscience International Limited is seeking a Regulatory Affairs professional responsible for supporting quality processes and regulatory compliance for medical devices. This role includes drafting submissions and ensuring adherence to regulations throughout the product lifecycle.

The ideal candidate will have a Bachelor's degree in a relevant field and 4-6 years of experience in Regulatory Affairs or a related industry with a strong understanding of FDA regulations. A collaborative spirit and detail-oriented mindset are essential for success.

Qualifications

• 4-6 years of experience in Regulatory Affairs or related field.
• Knowledge of FDA software lifecycle processes and documentation.
• Experience in medical device design and development.

Responsibilities

• Support regulatory activities throughout product lifecycle.
• Draft sections of regulatory submissions and technical protocols.
• Ensure compliance with software and cybersecurity requirements.

Skills

Regulatory Affairs

Design Assurance

Software Quality

Cybersecurity

Education

Bachelor of Science in Biology, Biochemistry, Software Engineering, etc.

Job description

Meridian Bioscience International Limited is seeking a Regulatory Affairs professional responsible for supporting quality processes and regulatory compliance for medical devices. This role includes drafting submissions and ensuring adherence to regulations throughout the product lifecycle.

The ideal candidate will have a Bachelor's degree in a relevant field and 4-6 years of experience in Regulatory Affairs or a related industry with a strong understanding of FDA regulations. A collaborative spirit and detail-oriented mindset are essential for success.