Regulatory Affairs Lead for Med Devices & SaMD

Myant Inc; Mississauga; Presencial; CAD 110 000 - 140 000; Tempo integral

Resumo da oferta

Myant Health is seeking an experienced Regulatory Affairs Manager to lead regulatory strategy and submissions for our medical device and SaMD portfolio in Canada, the United States and Europe. You will collaborate with Product, Engineering, Clinical, Quality and Manufacturing to align development with regulatory requirements.

The role requires hands-on experience with Health Canada, FDA and EU MDR pathways, including submissions (510(k)/De Novo, CE marking) and post-market activities, and deep

Qualificações

• Bachelor’s degree in a relevant field (Biomedical/Engineering/Life Sciences)
• Several years of regulatory affairs experience in medical devices
• Experience with Canada/US/Europe regulatory requirements
• Hands-on regulatory submissions experience (FDA/HC/EU)
• Experience with SaMD, digital health and wearable devices
• ISO 13485/MDSAP experience
• Experience with NPI and lifecycle regulatory activities
• Familiarity with eQMS and controlled documentation
• Audit experience or Internal Auditor
• RAC or ISO 13485 Auditor certification preferred

Responsabilidades

• Develop regulatory strategies for medical devices and software products
• Lead or support submissions across Health Canada, FDA and EU frameworks
• Prepare regulatory dossiers and technical documentation
• Support Health Canada MDL applications and amendments
• Assist FDA 510(k), De Novo submissions and interactions
• Contribute to EU MDR/CE marking activities
• Drive regulatory planning in NPI and design changes
• Maintain regulatory documentation in the eQMS
• Participate in internal audits and regulatory inspections

Conhecimentos

Regulatory affairs

SaMD/digital health

NPI

Regulatory submissions

ISO 13485

MDSAP

FDA/Health Canada/EC MDR

Cross-functional teamwork

Auditing

Project management

Formação académica

Bachelor’s degree in Biomedical Engineering or related field

Equivalent regulatory experience

Ferramentas

eQMS software

Regulatory databases

Descrição da oferta de emprego

Myant Health is seeking an experienced Regulatory Affairs Manager to lead regulatory strategy and submissions for our medical device and SaMD portfolio in Canada, the United States and Europe. You will collaborate with Product, Engineering, Clinical, Quality and Manufacturing to align development with regulatory requirements.

The role requires hands-on experience with Health Canada, FDA and EU MDR pathways, including submissions (510(k)/De Novo, CE marking) and post-market activities, and deep