We are seeking a Regulatory Officer for a well established R&D client of ours in the Vancouver area. The Regulatory Officer will collaborate with multiple stake holders within our clients organization. This position will provide regulatory affairs input into product development projects to ensure all regulatory requirements are met throughout the development process.
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Advantages
-Competitive compensation and benefits
-Opportunities for career advancement
Responsibilities
-Actively collaborate with to develop documentation to be submitted to regulatory
-Conduct periodic reporting and other activities required for the continued regulatory compliance
-Maintain current knowledge of FDA and Health Canada, guidance, and standards applicable to company products
-Interact with regulatory agencies such as the FDA, Health Canada, notified bodies as required for the processing of submissions, regulatory reports, and any other regulatory actions
-Compile and process materials for license renewals, updates, and registrations
-Assist with the implementation and maintenance of systems for tracking submissions, and changes thereof, sent to regulators and partners
-Review marketing material, labeling, and labels for compliance with regulatory requirements
-Actively participate in evaluation of regulatory compliance of changes to documents, products, processes, and test methods, and define the requirements for regulatory reporting of such changes
-Conduct post-market surveillance activities, including review of customer complaints, trend analysis, and reporting
-Ensure continued compliance to applicable regulations for operational activities
-Participate in research of regulatory issues and disseminate regulatory information to production, QA, QC, and senior management as required
Qualifications
-Bachelor's degree in a field relevant to this position
-Knowledge of FDA and Health Canada regulatory processes
-Great attention to detail with a goal-driven attitude.
-Excellent interpersonal communication and listening ability.
Summary
If you would like to be considered for this opportunity please forward your resume via email to Nick Paraskeva | nick.paraskeva@randstad.ca
Randstad Canada is committed to fostering a workforce reflective of all peoples of Canada. As a result, we are committed to developing and implementing strategies to increase the equity, diversity and inclusion within the workplace by examining our internal policies, practices, and systems throughout the entire lifecycle of our workforce, including its recruitment, retention and advancement for all employees. In addition to our deep commitment to respecting human rights, we are dedicated to positive actions to affect change to ensure everyone has full participation in the workforce free from any barriers, systemic or otherwise, especially equity-seeking groups who are usually underrepresented in Canada's workforce, including those who identify as women or non-binary/gender non-conforming; Indigenous or Aboriginal Peoples; persons with disabilities (visible or invisible) and; members of visible minorities, racialized groups and the LGBTQ2+ community.
Randstad Canada is committed to creating and maintaining an inclusive and accessible workplace for all its candidates and employees by supporting their accessibility and accommodation needs throughout the employment lifecycle. We ask that all job applications please identify any accommodation requirements by sending an email to accessibility@randstad.ca to ensure their ability to fully participate in the interview process.
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We are seeking a Regulatory Officer for a well established R&D client of ours in the Vancouver area. The Regulatory Officer will collaborate with multiple stake holders within our clients organization. This position will provide regulatory affairs input into product development projects to ensure all regulatory requirements are met throughout the development process.
Advantages
-Competitive compensation and benefits
-Opportunities for career advancement
Responsibilities
-Actively collaborate with to develop documentation to be submitted to regulatory
-Conduct periodic reporting and other activities required for the continued regulatory compliance
-Maintain current knowledge of FDA and Health Canada, guidance, and standards applicable to company products
-Interact with regulatory agencies such as the FDA, Health Canada, notified bodies as required for the processing of submissions, regulatory reports, and any other regulatory actions
-Compile and process materials for license renewals, updates, and registrations
-Assist with the implementation and maintenance of systems for tracking submissions, and changes thereof, sent to regulators and partners
...
-Review marketing material, labeling, and labels for compliance with regulatory requirements
-Actively participate in evaluation of regulatory compliance of changes to documents, products, processes, and test methods, and define the requirements for regulatory reporting of such changes
-Conduct post-market surveillance activities, including review of customer complaints, trend analysis, and reporting
-Ensure continued compliance to applicable regulations for operational activities
-Participate in research of regulatory issues and disseminate regulatory information to production, QA, QC, and senior management as required
Qualifications
-Bachelor's degree in a field relevant to this position
-Knowledge of FDA and Health Canada regulatory processes
-Great attention to detail with a goal-driven attitude.
-Excellent interpersonal communication and listening ability.
Summary
If you would like to be considered for this opportunity please forward your resume via email to Nick Paraskeva | nick.paraskeva@randstad.ca
Randstad Canada is committed to fostering a workforce reflective of all peoples of Canada. As a result, we are committed to developing and implementing strategies to increase the equity, diversity and inclusion within the workplace by examining our internal policies, practices, and systems throughout the entire lifecycle of our workforce, including its recruitment, retention and advancement for all employees. In addition to our deep commitment to respecting human rights, we are dedicated to positive actions to affect change to ensure everyone has full participation in the workforce free from any barriers, systemic or otherwise, especially equity-seeking groups who are usually underrepresented in Canada's workforce, including those who identify as women or non-binary/gender non-conforming; Indigenous or Aboriginal Peoples; persons with disabilities (visible or invisible) and; members of visible minorities, racialized groups and the LGBTQ2+ community.
Randstad Canada is committed to creating and maintaining an inclusive and accessible workplace for all its candidates and employees by supporting their accessibility and accommodation needs throughout the employment lifecycle. We ask that all job applications please identify any accommodation requirements by sending an email to accessibility@randstad.ca to ensure their ability to fully participate in the interview process.
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