Product Specialist
2 months ago
**About Us**
UniQ focuses on providing innovative immunoassay solutions for various challenges in rapid testing. With our Flow technology, UniQ is working to bring the next-generation rapid tests to life.
- What you will do:
Some specific duties and tasks include, but are not limited to, the following:
- Responsible for independently conducting experiments for research project and developing new product lines of **IVD medical devices**
- Responsible for drafting and coordinating the submissions of product regulatory registration. Communications with Health Canada/FDA/CE
- Deliver internal and external quality assurance scientific and technical SOPs to meet ISO 13485 requirements
- Troubleshoot and resolve complex scientific and technical investigations
- Prepare preliminary design specifications and draft design verification and validation test plans documentation
- Execute design verification and validation test plans as required
- Design and execute required stability studies
- Initiate and maintain design history files during early phases of product development
- Participate in risk management activities related with the product under development
- Generate technical documentation and provide pre-and post-product launch support
- Goal focused products and special assignments, including all admin/office jobs
**What you will need to be successful**:
- Bachelor or Master degree in a life sciences discipline (preferably biochemistry, microbiology, biology, biotechnology or related science)
- A minimum of 1 - 2 years’ experience in a medical device industry environment
- Strong technical knowledge on immunoassay, IVD test design, development, rapid test
- Knowledges of medical devices QA/RA requirements
- Skilled presenter to deliver technical summaries of data with critical thinking skills to provide in-depth analytical explanations and interpretations
- Ability to work in a dynamic and fast-paced team environment
Pay: $45,000.00-$50,000.00 per year
Schedule:
- Monday to Friday
Application question(s):
- What is you expected salary range?
Work Location: In person
Pay: $45,000.00-$50,000.00 per year
**Education**:
- Bachelor's Degree (required)
**Experience**:
- Presentation skills: 1 year (required)
Work Location: In person
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