Regulatory Affairs Assistant

2 weeks ago


Burnaby, Canada Artron Laboratories Inc. Full time

Artron Laboratories Inc is a technology-based manufacturer specialized in the development and large-scale production of lateral flow rapid test kits. Artron established itself in the progression of in vitro diagnostic lateral flow tests that have revolutionized the market for disease diagnosis and analyte detection. At Artron, we are committed to going above and beyond to meet the specific challenges faced by the rapid diagnostic industry participants. Our mission is to overcome industry challenges and provide simple and affordable IVD products that meet customer’s highest expectations.

This position is expected to assist the RA team on a diverse array of regulatory initiative teams and Artron product development. The RA Assistant will assist the regulatory activities to obtain and maintain product registration status in compliance with relevant regulations and procedures. Reporting to the RA Manager.

**Responsibilities**:

- Assists in reviewing and revising product labeling artwork including product labels for pouches, boxes, and instructions for use in accordance with the governing regulations and the company procedures.
- Coordinates and collects information from various departments (e.g. R&D, Product Development, QA etc.) to support regulatory projects.
- Participates in the review of new regulations and development of internal procedures.
- Assists in doing research and drafts technical documents for regulatory submissions.
- Assists with particular regulatory assessments when required.

**Education and Experience**:

- Bachelor’s degree in Life Science related study fields.
- 1+ years of experience working in biological, pharmaceutical and medical device industry.

**Qualifications**:

- Multitasking skills and willingness to actively seek information necessary to complete assignments.
- Excellent interpersonal skills at work.
- Willingness to take responsibilities and collaborate with other departments at work.
- Pay close attention to details.
- Active learning individual.
- Excellent verbal and written skills in English.

**Preferred**:

- Master’s degree in Life Science related study fields.
- 3+ years of experience working in biological, pharmaceutical and medical device industry.

**Benefits**:

- Dental care
- Extended health care
- Vision care

Schedule:

- 8 hour shift
- Monday to Friday

Work Location: One location



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