What are the responsibilities and job description for the Software Developer position at Trigent Solutions Inc.?
Title: Software Developer
Duration: Full Time Permanent
Client: FDA
Location: 100% Remote
Job Summary
We are looking for a talented Software Developer with a strong background in FDA-regulated environments. The ideal candidate will design, develop, and maintain software solutions while ensuring compliance with regulatory standards. If you have experience working directly with the FDA and are passionate about building high-quality software, we want to hear from you!
Key Responsibilities
Duration: Full Time Permanent
Client: FDA
Location: 100% Remote
Job Summary
We are looking for a talented Software Developer with a strong background in FDA-regulated environments. The ideal candidate will design, develop, and maintain software solutions while ensuring compliance with regulatory standards. If you have experience working directly with the FDA and are passionate about building high-quality software, we want to hear from you!
Key Responsibilities
- Design, develop, and maintain software applications in compliance with FDA regulations.
- Collaborate with cross-functional teams to gather requirements and translate them into technical specifications.
- Prepare and review documentation, including software validation plans and user manuals, to meet regulatory standards.
- Conduct software testing and validation to ensure functionality, performance, and compliance.
- Troubleshoot and resolve software issues, ensuring minimal impact on project timelines.
- Stay updated on industry trends and regulatory changes affecting software development in FDA-regulated environments.
- Participate in code reviews and contribute to best practices for software development and documentation.
- Provide technical support and training to end-users as needed.
- Bachelor’s degree in Computer Science, Software Engineering, or a related field.
- Minimum of 8 years of software development experience, particularly in FDA-regulated industries.
- Proven experience working with the FDA on software compliance and validation.
- Proficiency in programming languages such as Java, C#, Python, or similar.
- Experience with software development methodologies (Agile, Waterfall).
- Strong understanding of software quality assurance processes and regulatory requirements (e.g., 21 CFR Part 11).
- Excellent problem-solving and analytical skills.
- Strong communication skills, with the ability to work effectively in a team environment.
