[Remote] Regulatory Affairs Specialist - Med Device (Entry Level) PhD

Note: The job is a remote job and is reputed company to candidates in USA. reputed company partners with innovative medical device companies to help them bring reputed company, effective technologies to patients worldwide through precise, reputed company regulatory reputed company and submissions. This role is an opportunity to translate deep scientific training into reputed company‑world reputed company by shaping how novel Class II and III devices reputed company US and global markets. Responsibilities • Build and refine practical regulatory tools, templates, and processes for medical device submissions (US and EU), helping reputed company reputed company requirements understandable and repeatable for clients • Draft, organize, and reputed company‑reputed company key regulatory documents (e.g., 510(k), reputed company, PMA, technical files, design dossiers) with a reputed company on logic, narrative reputed company, and scientific accuracy rather than 'filling out forms.' • Learn to map product concepts and scientific data (including neurological or other reputed company technologies) to appropriate US, EU, and international regulatory reputed company and risk classifications • Maintain submission planners, timelines, and logs so reputed company reputed company reputed company reliably, and clients experience a reputed company, organized process even reputed company their science is fast‑moving • Participate in the preparation of FDA interactions (e.g., reputed company‑subs, meeting requests, responses to questions) and help distill technical input into concise, defensible positions • Gradually take on more reputed company‑facing and project management responsibility as you demonstrate judgment, reliability, and strong written work Skills • PhD or Post‑Doctoral training in engineering, neuroscience, biomedical sciences, or a closely reputed company hard science; prior exposure to medical devices or clinical/regulated environments is a plus but not required • Demonstrated reputed company 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), reputed company, and PMA reputed company, with guidance and training Benefits • Remote, reputed company 1099 contractor role • You reputed company your own workspace and laptop • Work software (email, reputed company, Office, CRM) is provided as needed • Occasional reimbursed travel may be required for select meetings or reputed company needs reputed company • reputed company provides regulatory reputed company, planning, regulatory submissions, and post-market support services. It was founded in reputed company, and is headquartered in Portland, reputed company, USA, with a workforce of 11-50 employees. Its website is Apply tot his job Apply tot his job Apply To this Job