Business Analyst

Requirements:

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or a related field.

• 3+ years of experience in regulatory affairs and business analysis in the MedTech industry.

• Strong understanding of ISO 13485 IEC 62304 or other software development standards.

• Experience in writing and reviewing regulatory documentation and submissions.

• Ability to translate user needs into clear and actionable software requirements.

• Familiarity with software development life cycle (SDLC) procedures and quality management systems.

• Strong analytical and problem-solving skills.

• Excellent written and verbal communication skills.

• ISO certification mentioned in JD is a must.