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 FDAregulated 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 highquality software we want to hear from you!
Key Responsibilities:
- Design develop and maintain software applications in compliance with FDA regulations.
- Collaborate with crossfunctional 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 FDAregulated environments.
- Participate in code reviews and contribute to best practices for software development and documentation.
- Provide technical support and training to endusers as needed.
Qualifications:
- Bachelors degree in Computer Science Software Engineering or a related field.
- Minimum of 8 years of software development experience particularly in FDAregulated 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 problemsolving and analytical skills.
- Strong communication skills with the ability to work effectively in a team environment.