Senior Technical Writer
Skills
Corrective And Preventive ActionData MappingDesign AssuranceDocument ManagementMedical Device ManufacturingMedical DevicesProofreading
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- 10 to 14 years experience with BA or 8 to 12 years with MBA
- Background in a regulated industry with strong preference for medical devices life sciences or pharmaceuticals
- Experience with design assurance and technical documentation including IFUs SOPs WIs validation protocols reports and risk files
- Hands on experience managing DCAs and supporting quality or regulatory documentation
- Ability to perform data mapping cross referencing and organize raw data into tables using software tools
- Strong proofreading editing and technical writing skills
- Experience with engineering documentation and concepts such as hazard analysis design validation usability and complaint review
Nice to have
- Detail oriented
- Organized
- Collaborative
- Clear communicator
- Analytical
- Concise writer
Day to day
- Write, revise, edit, and proofread technical engineering documents for regulated medical device projects
- Organize and synthesize technical inputs from engineering teams into clear documentation such as IFUs SOPs work instructions and quality records
- Manage DCAs data mapping cross referencing and project records while collaborating with internal teams and external partners
- Translate complex technical information into concise well structured documents that support design assurance and regulatory quality activities