Global Regulatory Affairs Manager (Doha)

Shifamed; Doha; On-site; QAR 291,226 - 436,839; Full time

Job summary

Shifamed is seeking a Manager / Sr. Manager in Regulatory Affairs to lead the regulatory strategy and submissions for its medical devices. This role involves close collaboration with Clinical, Quality, and R&D teams to support U.S. regulatory activities and global clinical studies.

The ideal candidate should have over 10 years of experience in the industry, particularly with FDA submissions, and be familiar with international regulatory pathways. This position offers a unique opportunity to shape regulatory strategy for a clinical-stage company.

Qualifications

• 10+ years of Regulatory Affairs experience within the medical device industry.
• Experience supporting clinical-stage medical device programs.
• Strong understanding of clinical evidence requirements.

Responsibilities

• Develop and execute global regulatory strategies.
• Lead preparation and submission of U.S. regulatory filings.
• Support clinical studies including regulatory submissions across multiple countries.

Skills

FDA medical device submissions

Regulatory strategy development

Cross-functional leadership

Clinical study support

Excellent written and verbal communication

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Job description

Shifamed is seeking a Manager / Sr. Manager in Regulatory Affairs to lead the regulatory strategy and submissions for its medical devices. This role involves close collaboration with Clinical, Quality, and R&D teams to support U.S. regulatory activities and global clinical studies.

The ideal candidate should have over 10 years of experience in the industry, particularly with FDA submissions, and be familiar with international regulatory pathways. This position offers a unique opportunity to shape regulatory strategy for a clinical-stage company.