Medical Device Regulatory Assistant
By Surgmed Group At Montreal, Quebec, Canada
Minimum College education or Accredited Certificate program preferred, with certifications in ISO 13485, MDSAP, CE, and/or FDA regulations.
Participate in internal and external audits to ensure compliance with regulatory requirements.
Keep abreast of changes in regulatory guidelines and requirements, communicating these changes to the relevant teams.
Previous work experience in regulatory affairs within ISO certified companies is mandatory.
Minimum of 2 years of relevant experience in a similar role.
Medical device experience is necessary; understanding of medical device classifications and regulations is essential.
Medical Device Risk Manager- Remote
By Varian At Canada
At least 3 years of relevant experience in medical device risk management
Leads Risk Management efforts, processes and process improvements for the Varian Products, with a main focus on Varian Digital Oncology.
Develops and maintains Risk Management Files that include risk management plans, hazard analyses and risk assessments
Keeps abreast of changes to regulations and standards as they bear on risk management
Minimum Required Skills And Knowledge
Bachelor’s degree in Science or Engineering with several years of related experience
Medical Device Logistics Analyst 1
By IQVIA At Montreal, Quebec, Canada
Knowledge of Medical Devices and Regulatory Requirements
Advise Project Management on correct shipping materials and documentation to order for global studies
Liaise closely with Project Management to ensure accurate address details in QLIMS
plays a key role in the ordering, management, and collection of worldwide field medical devices.
1-3 years of strong Global Shipping and Logistics experience is Required, preferably from another CRO or pharma company
Knowledge of Customs and International Shipping Regulations/Restrictions for Import/Export
Regulatory Affairs Specialist - Medical Device Contract
By Kelly Science, Engineering, Technology & Telecom At Canada
Basic project management and interpersonal skills and the ability to understand scientific concepts
Knowledge of Canadian regulatory requirements in medical devices
Collect and organize information on regulatory requirements for in vitro diagnostic devices, quality, preclinical and clinical data to meet applicable regulations.
Participate in device registration activities - agency communication; registration requirements; participation in drafting and preparing submission documents
Bachelor’s or Master's degree with 2+ years of related work experience
IVD experience is an asset