Partner with R&D/Hardware/Software teams to embed regulatory needs into roadmaps.
Evaluate device class, risk, and global approvals; design efficient docs.
Identify regulatory obstacles early and propose data-driven workarounds.
Prepare regulatory submissions (IDE, PMA, 510(k), international) with organized data.
Assess design/manufacturing/testing changes for regulatory impact.
Build internal tools, templates, and SOPs; train teams on compliance.

🎯 Requirements

Bachelor's Degree or higher in an applicable engineering discipline.
Strong technical writing and communication skills.
Excellent collaboration and organizational skills in fast-moving environments.

🎁 Benefits

Opportunity to work with leading experts from diverse fields.
Growth potential and rapid advancement.
Medical, dental, and vision insurance.
Paid holidays and commuter benefits.
Meals provided.
Equity (RSUs) for full-time employees.

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