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.