Regulatory Affairs Specialist (Entry-Level) – Recent PhD/Postdoc

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

If you are a scientist who wants your training to directly influence how new devices reach patients—and you are willing to learn fast, write well, and grow with a small team—this is a strong entry point into a long‑term regulatory affairs career.

About the role

Mittal Consulting partners with innovative medical device companies to help them bring safe, effective technologies to patients worldwide through precise, timely regulatory strategy and submissions. This role is an opportunity to translate deep scientific training into real‑world impact by shaping how novel Class II and III devices reach US and global markets. It is designed for someone who prefers ownership and mastery over complex problems, and who values mentorship, clarity, and long‑term collaboration.

What you will do

• Build and refine practical regulatory tools, templates, and processes for medical device submissions (US and EU), helping make complex requirements understandable and repeatable for clients.
• Draft, organize, and quality‑check key regulatory documents (e.g., Q-Subs, 510(k), De Novo, PMA, technical files, design dossiers) with a focus on logic, narrative flow, and scientific accuracy rather than “filling out forms.”
• Learn to map product concepts and scientific data to appropriate US, EU, and international regulatory pathways and risk classifications.
• Maintain submission planners, timelines, and logs, so projects move forward reliably, and clients experience a calm, organized process even when their science is fast‑moving.
• Participate in the preparation of FDA interactions (e.g., pre‑subs, meeting requests, responses to questions) and help distill technical input into concise, defensible positions.
• Gradually take on more client‑facing and project management responsibility as you demonstrate judgment, reliability, and strong written work.

Who will thrive here

This role is ideal for a recent PhD/Post‑Doc graduate in engineering, biomedical, or hard sciences who wants to pivot from pure research into regulatory and strategy work without giving up intellectual challenge.

You are likely to enjoy this if you:

• Learn new frameworks quickly and enjoy going from “I’ve never seen this” to “I can explain this clearly” in a short time.
• Have a low‑ego, ownership mindset: you care more about getting it right than being right, take editorial feedback well, and are willing to iterate your work product.
• Write clearly, succinctly, and logically; you are comfortable turning scattered inputs (emails, reports, data) into coherent, well‑structured documents.
• Prefer depth over title: you want to become a trusted regulatory thinker over time, not just “check a box” to get experience.
• Value loyalty and long‑term collaboration and are looking for a place where investing in the relationship is reciprocated with mentorship, flexibility, and increasing responsibility.

Qualifications and working conditions

• 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.Pharma background is not ideal.
• 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.
• Remote, flexible‑hours 1099 contractor role; you provide your own workspace and laptop, and work software (email, Zoom, Office, CRM) is provided as needed.
• Headquarters in Portland, Oregon; occasional reimbursed travel may be required for select meetings or client needs, (e traveling to Washington D.C for meetings with the FDA)

See what is it like to work at Mittal Consulting

https://www.youtube.com/watch?v=F_6LxNnT_V8&t=204s