We are seeking a skilled Technical Writer to support our client in their mission of improving cancer treatment through cutting-edge technology. If you have a passion for creating precise, regulatory-compliant documentation in the medical device industry and experience in radiotherapy, this role could be your next challenge.
Key responsibilities
- Collaborate with cross-functional teams, including regulatory specialists, product owners, clinical scientists, and engineers, to produce and maintain Product Life Cycle (PLC) documentation.
- Develop and update product documentation to ensure compliance with regulations and standards, including FDA and MDR.
- Create materials independently and with inter-departmental input to support the intended use, product lifecycle, and updates.
- Contribute to the creation of Instructions for Use (IFU) and DICOM conformance statements.
- Facilitate Verification and Validation (V&V) activities and document results.
- Maintain timelines for product lifecycle documentation and ensure adherence to planned changes.
- Manage PLC documentation processes and drive improvements in documentation management practices.
- Provide input for requirements management tools and V&V processes as applicable.
Required skills and qualifications
- Demonstrated experience in technical writing within the medical device industry.
- Familiarity with radiotherapy or radiology workflows; direct experience is a strong advantage.
- Excellent writing skills with an emphasis on regulatory-oriented documentation and the ability to synthesize complex technical information.
- Basic knowledge of MDR and FDA regulatory processes.
- A degree (BSc or MSc) in a relevant field such as engineering, healthcare, or life sciences.
- Fluency in English, both written and spoken.
Benefits
- Competitive salary and benefits package.
- Opportunity to work with cutting-edge technology in a rapidly growing company.
- Collaborative and innovative work environment.
- Potential for professional growth and development.
- Health insurance, company events, and team-building activities