Quality Assurance

2 weeks ago

Burlington, Canada Trinity Biotech Full time

**Reports to**:Quality Assurance Manager

**Education Requirements**: Minimum BS in biological sciences, Quality/Regulatory or similar degree preferred. Training with FDA QSR and GMP/GLP standards related to US and international IVD products.

**Experience/Qualifications**:

- Strong technical writing ability
- Experience working in a FDA regulated environment
- Experience with regulatory submissions and/or technical writing
- FDA inspection experience, in particular with design and development
- Quality system internal auditor training
- Understanding of biological science statistical techniques
- 510k experience
- Knowledge of immunology techniques preferred

Physical Effort: Listed below are the physical demands of the job according to percentage of time performing the tasks including any applicable weight movements.

**Summary of Position**:
Coordinate and document internal regulatory processes, such as internal audits, inspections, and license renewals. Responsible for managing 3rd party clinical studies and regulatory submissions, international product registration and executing plan to obtain IVD clearance for LDT services. Compile and edit materials for submission to regulatory agencies.

**Job Duties/Key Responsibilities**:
1. Technical writing in support of regulatory submissions
2. Assist with product registrations and CE marking of product.
4. Manage notarization of documentation
5. Compile and prepare materials for submission to regulatory agencies
6. Coordinate internal regulatory processes, license renewals or registrations.
7. Perform independent review of design files
8. Assist with ISO 13485/MDSAP compliance
9. Ensure regulatory compliance of marketing materials and website.
10. Preparation / review of technical files.
11. Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
12. Provide support to 60 Pineview, Amherst, NY, Reference Laboratory at 640 Ellicott St., Buffalo, NY, and Nova Century Scientific in Burlington, ON, Canada
13. Other duties as assigned

**Job Types**: Full-time, Permanent

Pay: $45,000.00 per year

**Benefits**:

- Paid time off

Schedule:

- 8 hour shift

Ability to commute/relocate:

- Burlington, ON: reliably commute or plan to relocate before starting work (required)

**Education**:

- Bachelor's Degree (preferred)

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