Technical Writer

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