--- Last Edited Time: '2026-06-16T19:10:00+00:00' title: Marketing Manager --- - ## **Associate Regulatory Writer & Project Manager** **Location:** Remote (U.S. only) **Job Type:** Full-time ### **About Us** Innolitics LLC is a remote-first company specializing in medical device software development and FDA regulatory consulting. Since 2012, we've partnered with medical device companies to bring innovative technologies to market. Our team of engineers, consultants, and domain experts works at the intersection of software engineering and regulatory compliance to deliver high-quality solutions. We are a growing, collaborative team that values clear thinking, attention to detail, and continuous improvement. If you're excited by the intersection of technology, medicine, and regulation---and enjoy organizing and clarifying complex information---you'll feel at home here. ### **About the Role** We're hiring an **Entry-Level Regulatory Writer and Project Manager** to help bring clarity and momentum to our regulatory projects. This hybrid role combines **technical writing**, **project coordination**, and **requirements elicitation**. You'll work closely with both clients and our internal team to support the development and FDA submission of Software as a Medical Device (SaMD). This is a fully remote position with travel 2-3 times a year to clients and our annual company retreat. ### **What You'll Do** - Support the creation of high-quality [FDA regulatory documentation](https://innolitics.com/articles/medical-device-software-regulations-best-practices-faqs-and-examples/) (e.g., Software Descriptions, Requirements Traceability, Risk Analyses, and Validation Plans). - Collaborate with engineers, clinicians, and regulatory consultants to clarify requirements, user needs, intended use, and indications for use. Read more about this [here](https://innolitics.com/articles/2022-04-27-design-inputs/). - Help keep projects on track by monitoring timelines, managing task boards, and coordinating with clients and internal stakeholders. - Ensure version control and accuracy across regulatory deliverables. - Learn and apply FDA guidance documents and relevant standards (e.g., IEC 62304, ISO 14971) under supervision. Here are [some](https://innolitics.com/articles/fda-guidance-content-of-premarket-submissions-for-device-software-functions/) [example](https://innolitics.com/articles/2023-cybersecurity-guidance/) [guidance](https://innolitics.com/articles/2023-ots-software-guidance/) [documents](https://innolitics.com/articles/2022-assessment-of-quantitative-imaging-guidance/) that you will become familiar with. - Actively participate in client meetings and document takeaways into actionable tasks. - Use Notion (our primary tool for project management and documentation) to stay organized and aligned with the team. ### **What We're Looking For** - Excellent attention to detail and strong organizational skills. - Clear, concise writing skills---especially for technical or scientific content. - A comfort with ambiguity and a knack for structuring messy information. - Interest in healthcare, medical technology, and/or regulatory science. - Familiarity with writing requirements, specifications, or technical documentation is a plus. - Experience coordinating projects or tracking tasks (e.g., using Notion, Jira, Asana, Trello, etc.) - Degree in biomedical engineering or a related field. - 0--2 years of experience in a regulatory, engineering, QA, or technical writing role (internships count!). ### **What We Offer** - Competitive base salary (\$65,000 -- \$80,000) depending on experience - 10% performance-based bonus - Fully remote work with flexible hours - Comprehensive PTO and Sick Days package - Partial healthcare reimbursement and automatic 3% contribution to a 401(k) retirement plan - Annual company retreat for team building and collaboration - Mentorship from experienced regulatory and software professionals - We expect associates to work 45 hours/week during your first year, with at least 5 hours being independent learning, with some guidance from our team members (most of the team works 40 hours/week), and we expect associates to be promoted within 2 years of joining. ### **How to Apply** Please email your resume and a cover letter (3--4 short paragraphs) explaining **why this role interests you** and **why you're a good fit**. We are hiring as soon as we find the right person---so don't hesitate to apply! If selected to move forward, you'll hear from our team within 2--3 business days.