New Job Posting: Regulatory Affairs Associate

Sarah Stone • June 10, 2024

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Are you passionate about regulatory affairs? Looking to join a team that cares about each individual employee? Want a future with an aggressively growing and highly successful company that rewards everyone's contribution and love health care? If this is you, here's your opportunity!


Responsibilities of this position include:


- Maintenance and continual improvement of the company’s quality system.

- Review, triage, and confirm complaints as per defined criteria, ensuring customer complaints are received and processed appropriately and consistently to meet regulatory requirements.

- Assign complaints (and process) to the appropriate subject matter experts for filed complaints that may require further investigation.

- Manage the corrective actions / preventative actions processes for all products in accordance with established company procedures including receiving, investigating, and closing product complaints.

- Manage quarantined inventory and investigate root origins to meet minimal threshold allowances.

- Complete key projects within the quality system such as traceability, vendor reviews, temperature monitoring, batch work processing, and receiving inspections.

- Other duties include Quality System Management, CAPAs, Design Changes, Technical File Revisions, eQMS updates, Annual Health Canada requirements (PSUR), Internal Audits, etc.


Must Haves:


- Experience with Health Canada.

- Experience with FDA & Europe (MDD/MDR) preferred.

- Experience with the following requirements: 

 1. ISO 13485:2016 / MDSAP

 2. FDA (21 CFR Part 820)

 3. MDR

- Post-secondary degree/diploma (Sciences).

- Experience working in a Good Manufacturing Practice (GMP) environment, as well as a good understanding of GMP principles.

- Post Market Surveillance experience is an asset.

- Computer literacy – including Outlook and Microsoft applications such as Word and Excel.

- Ability to work independently.

- Flexible and strong organizational skills to manage time and productivity level to meet department metrics.

- High level of personal integrity is required.

- Excellent communication and interpersonal skills.

- Strong problem-solving skills and attention to detail.


*This is an 18-month contract commitment to start, with future opportunities.*