Regulatory Affairs Specialist II (Med-Device)

Regulatory Affairs Specialist II Fully Remote (within US) | Flexible Hours | 40 hr/week If you are a regulatory professional with 3 to 5 years of experience preparing FDA medical device submissions, and you want your expertise to directly shape how new medical devices reach the market, this is an opportunity to be a part of the journey with Mittal Consulting. Prior experience at FDA is preferred. 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 hierarchy, 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-Sub, 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 (including neurological or other complex technologies) 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 If you have foundational regulatory experience, have prepared FDA medical device submissions, and want to grow in working directly with clients and different device specialties, your expertise to shape how new devices reach patients, this role puts that work at the center. Prior FDA experience is strongly preferred. 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 Degree in engineering, biomedical sciences, or a closely related science, with 3 to 5 years of regulatory experience preparing FDA medical device submissions; prior experience at FDA is preferred. 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.