The Regulatory Affairs / Quality Systems Technical Writer will support company growth and our product offerings with responsibility for the hands-on management of documentation supporting a variety of quality management systems with various scopes across a myriad of product types.
This is an internship role with the potential to convert to a full-time Regulatory Affairs or Quality Systems Associate position.
You will work within a cross-functional team to write, edit, review and finalize technical documents required for regulatory submissions of medical device products. You will review project documentation, assess necessary resources, and estimate timelines for documentation development and review. The candidate should have experience with authoring in an agile development environment.
As part of the Enzyme team, you’ll be helping customers get their innovative medical products to market faster. Your work will have real-world impact, and you’ll gain valuable knowledge of and experience applying US and European medical device documentation regulatory requirements. Such prior knowledge will be advantageous but is not required.
Candidates should have:
- BS in a technical field (e.g. regulatory science, medical product quality, engineering, biology, physics, or related discipline), or a MS/certification in an applicable field
- Experience drafting, reviewing, editing technical documents such as Standard Operating Procedures (SOPs), test protocols/reports, or summaries of report results, etc.
- Experience creating flowcharts using solutions such as Lucidchart or Microsoft Visio.
- 0.5-1 year regulatory affairs and/or quality systems/assurance experience
- 0.5-1 year technical writing experience, preferably in the medical device field and with experience in writing SOP documents and/or regulatory submissions, such as a 510(k).
- Experience with document change control systems.
You probably have these values:
1. You are a craftsperson who takes pride in seeing your work delight customers
2. You want to work with domain experts and skilled engineers on challenging problems
3. You want to work on a mission and not just a product
Enzyme is like TurboTax for the FDA.
Simultaneously for software engineers, Enzyme is like GitHub for regulated medical AI.
We make it much easier to get FDA governed technology to market. We believe medical AI and digital health products will mostly solve the $1.4 trillion (1,400,000,0000,000) of healthcare waste in the U.S.A.
Our platform takes much of the expensive guesswork out of getting these products to market safely and promptly. A big part of that, however, is navigating the dizzying array of regulations and bureaucratic guidelines.
WE: believe regulation is needed to keep patients safe, but that it shouldn't discourage innovation.
YOU: own making the complexity manageable so our customers can focus on shipping.
What you'll get to work on:
* Apply strategic thinking to design to deliver innovative end-to-end customer experience considering market needs, budget & capabilities
* Generate ideas and concepts, visualize them such that they are communicated effectively to the cross-functional team, leadership, partners, and customers
* Translate concepts into detail designs that illustrate simplicity, despite the complexity of the system
* Collaborate with engineering, marketing, product management.
* Deliver design concepts, wireframes, prototypes, and detail design specifications
* Propose and grow a visual Design System for the product
* Own the outcome – be aware of the customer impact, and advocate for delivering the best possible experience
What you will need:
* Some formal exposure & training that gives depth user research, critical thinking, and design (Human-Computer interaction, anthropology, engineering, etc.)
* A min of 4+ years product/UX design experience with a focus on SaaS software
* Significant knowledge of user experience design methods, innovation, ideation, storytelling, prototyping, concept visualization, design frameworks, and design principles
* Able to articulately explain the rationale behind design choices with a balance of passion and respect for other’s ideas
* Facilitative leadership skills applied to drive user-centered design processes, working collaboratively with customers, cross-functional team members, and business partners, that result in others learning from you and requesting to work with you in the future
* Organized, self-directed, efficient and able to manage multiple and complex projects your estimated timelines
* Expertise with design tools (we use Figma) and interactive prototyping (we use Webflow)
* Skilled in creating low fidelity prototypes to share with users in a fast, iterative manner
* Ability to produce complete and detailed design specifications promptly so that the team can continually move forward
* Occasionally, you will be deployed to customer sites to do research and feedback sessions. Twice annually we do a company retreat to build community with our remote folks. Typically held in California (to share the Tahoe/Wine Country vibes).
Remote & WFH
We use modern tools (Slack, Zoom, ClickUp, Figma) in order to maintain a sanely structured, high context environment for all.
You will be a key collaborator for the VP of Product and founders. So we are excited to have you in the SF office with us.
But, we support working from home a couple of days a week. Or occasionally remote, if it helps your creative process.