Job Description
Artron is a leader in the medical devices industry, specializing in rapid diagnostics products. Headquartered in British Columbia, our operations span globally to meet the various needs of partners around the world. We pride ourselves on providing the best products and customer service to our clients through innovative technology and collaborative work culture.
Our BC head office location is seeking a well-rounded, full-time Regulatory Affairs Associate to work closely with Product Development on projects and company-wide initiatives to meet business objectives.
What you will do:
- Support regulatory activities related to the product registrations in Rest-of-the-World markets, including but not limited to the WHO /FDA and countries in Asia, Africa and Latin America, including:
- Creating or revising regulatory submissions in desired formats.
- Facilitating document authentication and legalization.
- Providing routine project updates.
- Liaising with ROW business partners as needed.
- Create, review and revise product labelling artwork including product labels for pouches, boxes, and Instructions for Use in accordance with the governing regulations and the company procedures.
- Review and provide input into marketing and sales materials to ensure compliance with the governing regulations and company procedures.
- Prepare annual reports and renewal submissions to various regulatory jurisdictions.
- Actively review new external standards/regulations updates globally and communicate pertinent information. Update the required tracking sheets on a routine basis.
- Prepare complex submissions including change notifications, amendments and initial applications to US FDA, Health Canada, Notified Body and WHO:
- PMA supplements, 510(k)s, new PMAs, Health Canada MDLs, Notified Body/Competent Authority applications, WHO and dossier submissions to other international Competent Authorities.
- Maintain a good working relationship by interacting proactively and persuasively with global regulatory agencies to gain approvals.
What you will need to be successful:
Required:
- Bachelor or Master’s degree in Life Sciences.
- 2+ years of experience in Regulatory or other related disciplines in the medical device/ pharmaceutical biologics industry.
- An understanding of regulatory requirements from Health Canada, EU, US, WHO.
- Experience liaising with Regulatory Authorities, i.e., US FDA, Health Canada, Notified Bodies is an asset.
- Excellent communication skills in teams and willingness to work in a collaborative environment.
- Able to work under pressure and fast- pace working environment.
Preferred:
- Strong English writing skills in Life Science related topics
- Mandarin, Chinese
Job Type: Full-time
Benefits:
- Dental care
- Vision care
Schedule:
- 8 hour shift
Experience:
- regulartory of medical device/ pharmaceutical biologics: 2 years (Required)
Education:
- Bachelor’s Degree (Required)
Language:
- Chinese (Preferred)
Work remotely:
- No