Description Acara Solutions is seeking a Technical Writer for a 6-12 month contract with a strong understanding of the EU Medical Device Regulation (MDR), a background in dental products, and experience with BSI auditors.
The successful candidate will be responsible for creating and updating 18 technical files to ensure compliance with the new EU MDR requirements.
The focus will be on dental products relating to bands, elastics, passive self-ligating brackets, archwires, instruments, adhesives, stainless steel accessories, and coil springs.
Pay rate : $50-62 / hr, DOE Schedule : M-F, fully onsite preferred but can also be Hybrid / Work from Home. Responsibilities
Create and update 18 technical files for dental products within the contract period in accordance with the new EU MDR requirements.
The products include bands, elastics, passive self-ligating brackets, archwires, instruments, adhesives, stainless steel accessories, and coil springs.
- Interpret and apply EU MDR regulations to ensure all documentation is compliant.
- Collaborate with cross-functional teams including Engineering, Quality Assurance, and Regulatory Affairs to gather necessary information for technical file creation.
- Manage documentation related to clinical evaluations, risk management, and post-market surveillance.
- Stay updated with changes in EU MDR regulations and guidelines and ensure these changes are reflected in the technical files.
- Understand dental product specifications and translate complex product information into clear, polished, and engaging content.
- Liaise with BSI auditors to ensure all technical files meet audit requirements.
Job Requirements Required Skills / Qualifications : Minimum 5 years of experience in technical writing Preferred Skills / Qualifications :
- Bachelor's degree in a related field. Advanced degree preferred.
- Proven experience as a Technical Writer in the medical device industry, preferably with dental products.
- Experience working with BSI auditors.
- Strong knowledge of EU MDR and other relevant regulations.
- Excellent written and verbal communication skills.
- Strong attention to detail and ability to work in a fast-paced environment.
- Proficient in MS Office and familiarity with document management systems.
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