Regulatory Affairs Specialist (Entry-Level)

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. This role is designed for someone who prefers ownership and mastery over complex problems, and who values mentorship, clarity, and long-term collaboration.

Key Responsibilities

• 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.
• 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 to ensure projects move forward reliably.
• 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 judgment, reliability, and strong written work are demonstrated.

Qualifications & Tech Stack

• PhD or Post-Doctoral training in engineering, neuroscience, biomedical sciences, or a closely related hard science.
• 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.
• Remote, flexible-hours 1099 contractor role.
• Provided software includes: email, Zoom, Office, CRM.
• Headquarters in Portland, Oregon.

Ideal Candidate Profile

• Willingness to learn fast, write well, and grow with a small team.
• Preference for ownership and mastery over complex problems.
• Values mentorship, clarity, and long-term collaboration.
• Learns new frameworks quickly and enjoys going from "I've never seen this" to "I can explain this clearly" in a short time.
• Possesses a low-ego, ownership mindset; cares more about getting it right than being right, takes editorial feedback well, and is willing to iterate work product.
• Writes clearly, succinctly, and logically; comfortable turning scattered inputs into coherent, well-structured documents.
• Prefers depth over title; aims to become a trusted regulatory thinker over time.
• Values loyalty and long-term collaboration.

Prior exposure to medical devices or clinical/regulated environments is a plus but not required.

Pharma background is not ideal.

Occasional reimbursed travel may be required for select meetings or client needs.