EMPLOYER: High Tech Genesis
High Tech Genesis is looking for a Technical Writer. If you are capable of delivering well written documentation of product specification, and managing regulatory risks, issues and changes then we want you on our team.
Required Skills and Experience:
- a degree in a scientific or legal field and one year of professional experience in regulatory affairs/quality management systems related to medical devices, OR
minimum of 4 years of professional experience in regulatory affairs/quality management systems related to medical devices.
- Formal training in technical writing
- Knowledge of 21 CFR, SOR 98-282 Canadian MDR, EU 2017/745 MDR
- Proficient in writing regulatory submissions for example 510(k), Health Canada licence applications, and Technical Files for CE Mark
- Capability of working with Adobe FrameMaker, InDesign, Illustrator, and Acrobat
- Past demonstrated ability to translate technical information into well written documentation
- Strong attention-to-detail, customer-centric service instinct, and organizational skills
Note 1: You MUST be legally entitled to work in Canada (i.e., possess Canadian Citizenship, Permanent Residency or Valid Work Permit)
Note 2: High Tech Genesis Inc. is an Equal Opportunity Employer.
Note 3: Accommodations are available upon request for all aspects of the hiring process.
Note 4: Please submit a MS Word version of your resume when applying for this position.
Please forward a MS Word version of your resume to: firstname.lastname@example.org
START DATE: 03/02/2021