Senior Regulatory Affairs Manager - Med Tech (Remote)

T45 Labs; Santa Clara (CA); Remote; USD 129,000 - 152,000; Full time

Benefits offered by this job

Bonus opportunities

Equity

Benefits package

Job summary

VahatiCor is seeking an experienced Regulatory Affairs Manager to develop regulatory strategies and manage submissions for cardiovascular device programs. The role emphasizes IDE/PMAs, collaboration with R&D, Clinical, Quality, and Manufacturing, and coordination with external experts.

The position is remote with travel to Santa Clara, CA headquarters and potential international duties. Five years of regulatory experience and strong documentation skills are required.

Qualifications

• Bachelor’s degree in chemistry, pharmacy, life sciences, engineering, or related field.
• Minimum of five years of regulatory affairs experience.
• Medical device regulatory experience including FDA submissions.

Responsibilities

• Develop and maintain US and international regulatory strategies; align with development and commercialization.
• Prepare and coordinate FDA submissions (IDE, PMA) and related filings.
• Coordinate clinical study regulatory submissions and safety reporting.
• Maintain regulatory records and ensure inspection readiness.
• Collaborate with R&D, Clinical, Quality, and Manufacturing across programs.

Skills

Regulatory knowledge

FDA submissions

Technical writing

Documentation

Cross-functional collaboration

Education

Bachelor's degree in science

Job description

VahatiCor is seeking an experienced Regulatory Affairs Manager to develop regulatory strategies and manage submissions for cardiovascular device programs. The role emphasizes IDE/PMAs, collaboration with R&D, Clinical, Quality, and Manufacturing, and coordination with external experts.

The position is remote with travel to Santa Clara, CA headquarters and potential international duties. Five years of regulatory experience and strong documentation skills are required.