Regulatory Strategy Associate, Med Devices – Remote

Mittal Consulting; United States; Remote; USD 69,000 - 103,000; Full time

Benefits offered by this job

Remote work

Flexible hours

Laptop provided as needed

Job summary

Mittal Consulting is seeking a PhD or Post‑Doc in engineering or biomedical sciences for a regulatory affairs role focused on shaping US and global medical device submissions. You will craft and review documents for 510(k), De Novo, PMA, and related files, and map data to appropriate regulatory pathways.

The position is a remote, flexible‑hours contractor role with occasional travel from Portland, OR as needed.

Qualifications

• PhD or Post‑Doctoral training in engineering, neuroscience, biomedical sciences, or a closely related hard science; prior exposure to medical devices or clinical/regulated environments is a plus but not required.
• Demonstrated excellence in scientific or technical writing (e.g., manuscripts, grant sections, white papers, protocols) and careful document review.
• Strong organizational habits, comfort managing multiple workstreams, and responsiveness to deadlines.
• Interest in developing expertise in FDA and EU medical device regulations, including 510(k), De Novo, and PMA pathways, with guidance and training.

Responsibilities

• Build and refine regulatory tools, templates, and processes for medical device submissions (US and EU).
• Draft, organize, and quality‑check regulatory documents (Q-Subs, 510(k), De Novo, PMA, technical files).
• Map product concepts and data to US, EU, and international regulatory pathways and risk classifications.
• Maintain submission planners, timelines, and logs for orderly project progress.
• Assist in FDA interactions and distill technical input into concise positions.
• Gradually take on more client‑facing and project management responsibilities.

Skills

Regulatory writing

Project management

FDA knowledge

Scientific communication

Education

PhD or Post‑Doc in engineering/biomedical sciences

Tools

Office suite

CRM

Zoom

Job description

Mittal Consulting is seeking a PhD or Post‑Doc in engineering or biomedical sciences for a regulatory affairs role focused on shaping US and global medical device submissions. You will craft and review documents for 510(k), De Novo, PMA, and related files, and map data to appropriate regulatory pathways.

The position is a remote, flexible‑hours contractor role with occasional travel from Portland, OR as needed.