Summary
Develop, edit, and maintain high-quality Instructions for Use (IFUs), labels, and documentation to support clinician needs, patient safety, and regulatory compliance. Collaborate with cross-functional teams to ensure accuracy, clarity, and adherence to industry standards.
Job Details
Employment type: Contract
Pay Range: $38 - $45 per hour
Location: Hybrid, Twin Cities Metro
Role Overview:
As a Technical Writer, you will be responsible for creating and updating technical documentation that ensures regulatory compliance and supports clinical use. You will collaborate with engineering, quality, regulatory, and marketing teams to produce clear, accurate materials. Your work will play a crucial role in maintaining product safety and regulatory adherence while simplifying complex technical information for diverse audiences. This role requires attention to detail, project management skills, and the ability to work effectively within a regulated medical environment.
Day in the Life
- Write and update clinician IFUs, patient manuals, and product labels.
- Review documents with cross-functional teams to ensure accuracy.
- Maintain detailed revision histories and supporting documentation.
- Manage multiple documentation projects simultaneously.
- Ensure all materials meet FDA, ISO, and EU MDR standards.
Your Qualifications
- Bachelor's degree in technical communication, engineering, English, or life sciences.
- 2+ years of technical writing experience in regulated environments.
- Proficiency with Microsoft Office, Adobe Creative Suite, and Content Management Systems.
- Strong attention to detail and critical thinking skills.
- Experience ensuring regulatory compliance and document control.
- Knowledge of medical terminology and labeling standards.
- Experience with XML-based content management systems (preferred).
- Ability to communicate complex technical information clearly.
- Skilled at cross-functional collaboration and project management.
- Strong problem-solving skills and risk assessment experience.
- Proven ability to simplify dense technical language for diverse audiences.
- Experience working in medical device or healthcare industries.
What We Believe In
Celarity believes a key part of creating happy careers is first creating inclusive connections for ALL talent through exposure and access. Celarity knows the importance of providing exposure, access, and equitable opportunities and is on a mission to connect open, qualified, and available candidates to careers in the Marketing, Creative, Digital, Operations, Human Resources, and Financial industries. Celarity is an Equal Opportunity Employer. For Celarity, it’s about the quality of relationships through ethical business practices. We have a responsibility to employees, clients, and the community. Hiring decisions are made without regard to: Race • color • creed • religion • national origin • gender • age • marital status • disability • public assistance status • veteran status • sexual orientation or any other characteristic protected by federal, state, or local laws.
