Microbix Biosystems is a fast growing biotechnology company based in Mississauga.
Founded in 1988 as a producer of infectious disease antigens, primarily for the diagnostics market, Microbix invests in the virology business to build capacity and develop new products to address emerging market opportunities, while enhancing manufacturing and laboratory capabilities and technologies.
Our emerging products take aim at large market opportunities. With Microbix' core competencies in the Diagnostics business, including cell culture, molecular biology, and GMP quality system, these new products build on Microbix' strength.
We are currently hiring for the following positions:
Reporting to the Director of QA and Compliance, a Regulatory and Compliance Associate will work in the QA and Compliance department to support various activities related to the upkeep of our ISO 9001 and ISO 13485 Quality Management System. Also will participate in various regulatory submissions to EU, FDA and Health Canada. This includes organizing and assembling medical device license applications and regulatory dossiers to EU Notified Body, FDA and Health Canada.
Skills and/or Knowledge Required
• Good knowledge of the European, US, and Canadian guidelines / policies regarding regulatory preparations/ submissions
• Experience with CE Technical File and Design Dossier Requirements
• Organization and time management skills
• Strong computer skills, mainly in the use of Microsoft Office
• Strong written and verbal communication skills and Interpersonal skills
• Commitment to team work
• Detail oriented
• 3-5 years of experience in regulatory affairs in a related field; experience within the medical device industry is preferred
• Assist in preparation of regulatory submissions to EU Notified Body, FDA and Health
Canada as required.
• Upgrade, as necessary, the Quality Management System (QMS) to meet regulatory requirements.
• Administer the postmarketing surveillance program. Ensure timely investigations of product complaints. Ensure appropriate identification and disposition of product lots related to product complaints based on complaint findings.
• Track and maintain regulatory correspondence and submissions. Review change control requests and determine regulatory filing requirements.
• Provide regulatory support to internal customers (Research & Development, Quality Control, Operations, Sales & Marketing), as required.
• Ensure the practical and effective risk management program that meets regulatory requirements. Ensure that risks are assessed based on their impact on materials, equipment, products, processes or other planned activities.
• Assist in reviewing batch product records. Provide guidance to manufacturing and quality control operations upon request and coordinate product release in a timely manner.
• Participate in conducting internal audits, encompassing the full scope of site operations. Apply risk-based principles.
• Actively support the QA and Compliance department to maximize efficiencies, performance and productivity.
• Please submit your resume and cover letter at email@example.com