Quality System and Regulatory Affairs Coordinator
Rogue Research Inc. is currently looking for a Quality and regulatory affairs coordinator to join its team. The Quality and regulatory affairs coordinator will work closely with the different teams to ensure compliance to the quality system and regulatory requirements. More precisely, this person will be responsible to:
- Write, maintain and improve the quality manual and related procedures (SOP) and forms.
- Perform internal training and follow-up with employees to ensure efficiency of the quality system.
- Coordinate internal and external audits.
- Manage corrective and preventive actions, nonconformities, complaints etc.
- Prepare, with design teams, regulatory submissions for medical devices.
Prerequisites:
- Minimum 3 years work experience in quality system management
- Creative and autonomous
- Bilingual (English and French)
Assets:
- Excellent knowledge of ISO 13485:2016/MDSAP.
Advantages of working at Rogue Research:
- Stimulating work environment where innovation and creativity are used to develop unique tools that contribute to the advancement of medical research and improves the lives of patients.
- Offices in the Mile-Ex in the heart of the newly forming AI hub in Montreal
- Flexible work hours
Interested candidates are invited to send their cv in PDF format to cv@rogue-research.com.
Project Coordinator
Rogue Research Inc. is currently looking for a project coordinator to join its R&D team.
The project coordinator will work closely with the product development and production teams on several medical device projects simultaneously. More precisely, the project coordinator will be responsible to:
- Write and update specification documents for different medical device projects.
- Perform literature reviews to have a better understanding of the different applications of similar products on the market.
- Review applicable standards (IEC, MDSAP) and ensure that they are taken into consideration in specifications and other documents.
- Plan, write and maintain risk analysis documentation related to medical devices.
- Define and maintain project schedules.
- Manage certification projects (IEC) and coordinate with certification laboratories.
- Assist engineering in the development of verification protocols and their execution.
- Coordinate transfer to production of new medical devices.
- Maintain DHF, DMR and DHR documentation.
Prerequisites:
- Engineering degree (e.g. biomedical, electrical, mechanical)
- Minimum 1 year work experience
- Creative and autonomous
- Bilingual (English and French)
Assets:
- Knowledge of IEC 60601 standards.
- Experience in an ISO 13485/MDSAP work environment.
- Interest and/or experience in the biomedical field.
Advantages of working at Rogue Research:
- Stimulating work environment where innovation and creativity are used to develop unique tools that contribute to the advancement of medical research and improves the lives of patients.
- Offices in the Mile-Ex in the heart of the newly forming AI hub in Montreal
- Flexible work hours
Interested candidates are invited to send their cv in PDF format to cv@rogue-research.com.