Mittal Consulting · 2 weeks ago
Regulatory Affairs Specialist - Med Device (Entry Level) PhD
United States
Full-time
Remote
New Grad, Entry LevelMittal 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.
ConsultingHealth CareMedicalMedical Device
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., 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
Qualification
Required
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
Benefits
Remote, flexible‑hours 1099 contractor role
You provide your own workspace and laptop
Work software (email, Zoom, Office, CRM) is provided as needed
Occasional reimbursed travel may be required for select meetings or client needs
Company
Mittal Consulting
Mittal Consulting provides regulatory strategy, planning, regulatory submissions, and post-market support services.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase