This role involves collaborating closely with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations, and Product Performance Analysis teams to review, approve, and support deliverables throughout the software development lifecycle.
Key Responsibilities:
- Consult with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations, and Product Performance Analysis teams to ensure compliance with software development procedures and industry regulations.
- Review and approve deliverables throughout the software development lifecycle.
- Lead Hazard Analysis activities with cross-functional teams.
- Occasionally assist in developing Standard Operating Procedures (SOPs) and Work Instructions tailored to software development activities.
- Provide occasional training sessions on specific software development activities.
- Write and execute test protocols and reports as needed.
Qualifications:
- Bachelor’s degree in Computer Science, Engineering, or related field.
- 3-5 years of experience in software development compliance, preferably in a regulated industry such as medical devices or pharmaceuticals.
- Strong understanding of software development lifecycle methodologies (e.g., Agile, Waterfall).
- Familiarity with industry regulations and standards (e.g., FDA regulations, ISO 13485, IEC 62304).
- Excellent communication and collaboration skills, with the ability to work effectively across diverse teams.
