Remote Regulatory Affairs Specialist II – Med-Device

Mittal Consulting; United States; À distance; USD 83 000 - 152 000; Plein temps

Résumé du poste

Mittal Consulting is recruiting a regulatory professional to help bring FDA medical devices to US and global markets. The role emphasizes ownership, clarity, and collaborative impact, with 1099 contractor terms and fully remote work within the United States.

The ideal candidate has 3–5 years of regulatory experience, strong scientific writing, and a passion for translating complex data into clear regulatory strategies. Prior FDA exposure is preferred and mentorship is offered.

Qualifications

• 3–5 years of regulatory experience preparing FDA medical device submissions.
• Strong scientific/technical writing and careful document review.
• Excellent organizational skills and ability to manage multiple workstreams.
• Interest in FDA and EU device regulations, including 510(k), De Novo, PMA.
• Remote, flexible-hours 1099 contractor role with provided software as needed.
• Headquarters located in Portland, OR with occasional travel.

Responsabilités

• Build regulatory tools, templates, and processes for US and EU submissions.
• Draft and quality-check key regulatory documents (Q-Sub, 510(k), De Novo, PMA).
• Map product concepts to regulatory pathways and risk classifications.
• Maintain submission planners, timelines, and logs for orderly progress.
• Assist in FDA interactions and distill technical input into concise positions.
• Grow into client-facing and project management responsibilities.

Connaissances

Regulatory writing

Project management

Client communication

Regulatory submissions

Formation

Engineering/Biomedical degree

Outils

Zoom

Office

CRM

Description du poste

Mittal Consulting is recruiting a regulatory professional to help bring FDA medical devices to US and global markets. The role emphasizes ownership, clarity, and collaborative impact, with 1099 contractor terms and fully remote work within the United States.

The ideal candidate has 3–5 years of regulatory experience, strong scientific writing, and a passion for translating complex data into clear regulatory strategies. Prior FDA exposure is preferred and mentorship is offered.