Senior Regulatory Strategy Lead — Med Devices & SaMD

Roche Holding AG; Tucson (AZ); On-site; USD 127,000 - 235,000; Full time

Job summary

Roche Holding AG in Tucson, AZ seeks a Senior Regulatory Affairs Manager to steer regulatory strategies for diagnostic instruments and software. You will shape submissions globally, manage health authority interfaces, and guide cross-functional teams from development to market access.

This onsite role emphasizes leadership, problem solving, and strategic influence across regions. Applicants should have 5–10 years in regulatory affairs for IVDs/Med devices, with US/EU experience, and a strong

Qualifications

• Advanced degree is considered an advantage.
• Experience with regulatory affairs in IVDs/Medical devices or Pharma is preferred.
• Knowledge of US, EU, China and international regulations is beneficial.

Responsibilities

• Oversees development of submission dossiers and global regulatory plans.
• Builds and maintains health authority relationships and represents Roche in audits.
• Leads regulatory strategy for evolving regulatory environments across regions.
• Manages complex external initiatives and stakeholder negotiations.
• Drives risk-based decision making and agile regulatory solutions.
• Mentors junior team members in regulatory submissions.

Skills

Regulatory strategy

Stakeholder management

Cross-functional collaboration

Audit readiness

Global submissions

Problem solving

Education

Bachelor’s / Master degree in Life Science or related field

Job description

Roche Holding AG in Tucson, AZ seeks a Senior Regulatory Affairs Manager to steer regulatory strategies for diagnostic instruments and software. You will shape submissions globally, manage health authority interfaces, and guide cross-functional teams from development to market access.

This onsite role emphasizes leadership, problem solving, and strategic influence across regions. Applicants should have 5–10 years in regulatory affairs for IVDs/Med devices, with US/EU experience, and a strong