MetaOptima Technology Inc. is one of Canada’s fastest growing startups looking for a highly-driven and talented individual interested in working with our core management team. We design and build complex and cool devices and software and develop the next generation of mobile and web digital health solutions. Our goal is to facilitate faster and more accurate care for anyone, anywhere. We are focused on empowering physicians with mobile health technologies and providing tools for dermatology and the early detection of skin cancer.
Role & Responsibilities:
Development and execution of regulatory strategies
Accountable for regulatory compliance and Management of company privacy and security program.
Assessment, approval and regulatory implementation of change requests
Review and approval of product related labeling and marketing material
Monitoring medical device regulatory environment
Training internally on relevant procedures and requirements
Participation in cross functional design and development projects
Accountable for Privacy and Security Management
Audit Software and Hardware department
Manage communication with certification bodies, regulatory agencies, internal stakeholders and external consultants
Plan and Manage budget associated to regulatory activities
Other Compliance projects related to Hardware/Software, as needed
Supporting the design and implementation of clinical and research studies
Supporting the grant proposal submissions and managing all regulatory requirements (privacy, security, etc. ) for clinical research projects
Managing the overall efficient day-to-day management of the trial, recruitment, retention, training, appraisal and supervision of trial team members, establishment of procedures to ensure adherence to trial protocols and administrative requirements, ensuring the timely recruitment of trial participants with secure randomisation processes and subsequent efficient and effective data management.
Monitoring trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems
Planning and supporting the meetings and work of the various groups and bodies associated with the trial, and creation and maintenance of all trial files, including the trial master file, and oversight of site files.
Managing all regulatory submissions for approvals for the results of the clinical studies in the target markets
Bachelor’s degree in Business Administration/ Juris Doctor degree or a related scientific discipline, or equivalent
Minimum 2 years’ experience in regulatory affairs - medical device and technology
Must have experience working in a multinational regulatory environment.
Experience in preparation and participation in notified body audits and competent authorities’ inspections
Fluent in English; further languages are an advantage
Must have experience planning and Implementing ISO compliance projects, preferably ISO 13485, 27001 or 9001.
Experience as Internal Auditor
Must have experience implementing and maintaining Privacy Programs: GDPR, PIPEDA, HIPAA, etc.
Experience in Medical device registration/license: Health Canada, FDA, TGA, MedSafe, Anvisa, CE Mark.
Situated in the heart of downtown, our office is steps away from the SkyTrain, SeaBus and West Coast Express. We offer a competitive salary, above industry-standard vacation, stock options, smartwatches (at the completion of the probation period and a comprehensive benefits package (including extended health, vision, and dental). Our environment is one where you can thrive in! With ergonomic chairs, a sit-stand desk and a kitchen stocked with snacks!