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Regulatory Affairs Officer Jobs in British Columbia

Regulatory Affairs Specialist - Medical Device
By ClinChoice At Greater Toronto Area, Canada
Document review of product changes due to EU MDR impact and the management of any required submissions.
Extracting available documents from the document management databases and operational systems to assist in the preparation of dossiers.
Minimum of one year of working experience in Medical Device industry specific to Health Canada
Knowledge of ISO13485, EU MDD/MDR, and Health Canada MDEL/MDL applications is required
Strong organizational skills including attention to detail, good planning and communication skills are required
Must possess excellent written and verbal communication skills
Director Of Regulatory Affairs - Medical Device/Pharma
By Akkodis At Scarborough, Ontario, Canada
· 10 to 12 years working experience
Experience working directly with the FDA on regulatory filings/strategy is required
· Experience with electronic submissions/the electronic submission process
Knowledge of how regulatory agencies operate, structure and process
Staying updated on regulatory requirements:
This is on site, 5 days a week role – for Canada, Scarborough location.
Regulatory Affairs Jobs
By Tag At Greater Toronto Area, Canada
•Experience in the delivery and management of complex quality assurance solutions
MUST HAVE EXPERIENCE AND INDICATED ON RESUME WITH MLR SUBMISSIONS, PAAB and VEEVA PROMOMATS SUBMISSIONS
•A Bachelor’s degree or equivalent experience is required
•Over 6 years’ experience in print and/or digital, or regulatory Quality Assurance environments
•Medical, pharmaceutical, or Life Sciences marketing experience preferred
•Excellent client facing and customer service skills
Quality Assurance And Regulatory Affairs Analyst
By Intellijoint Surgical Inc. At Kitchener, Ontario, Canada
Experience working within a Quality Management System (QMS)
Strong organizational, time management, and prioritization skills.
Support system administration of Quality Management System software.
Skills and Experience to Enable Success:
A continuous learner that builds on their existing knowledge of medical device and biomedical technology regulations
Collaborate with cross-functional teams and interface with external parties to meet quality requirements within project timelines.
Director Of Regulatory Affairs
By Akkodis At Scarborough, Ontario, Canada
· 10 to 12 years working experience
Experience working directly with the FDA on regulatory filings/strategy is required
· Experience with electronic submissions/the electronic submission process
Knowledge of how regulatory agencies operate, structure and process
Staying updated on regulatory requirements:
Preparing and submitting regulatory submissions:
Global Regulatory Affairs & Advisory Manager – Chemicals
By lululemon At Vancouver, British Columbia, Canada
Previous Project Management experience is an asset
Previous experience with the development and implementation of a Restricted Substances List or related chemicals management programs is an asset
In collaboration with the Chemicals Management Team, ensure regulated standards are reflected in annual updates to lululemon’s Restricted Substances List
Experience with national and/or international chemical laws and regulations applicable to adult apparel and accessories, , foods, electronics and equipment
Experience with regulatory, government and industry or standards organizations
Experience with legal and regulatory action is desired
Vp, Health Policy And Regulatory Affairs
By Kelly Science, Engineering, Technology & Telecom At Greater Toronto Area, Canada
Strong leadership and management skills and demonstrated ability to manage, support and motivate self-and others, sharing enthusiasm for organizational goals.
Communicate effectively, both orally and in writing, with experience preparing and adapting messaging that corresponds to the appropriate audience.
Facilitation and committee experience required, including the demonstrated ability to drive consensus at the senior leadership level.
Demonstrates good judgement as well as excellent people skills.
Identify and facilitate policy alignment as appropriate with health professional organizations, NGOs, allied industry associations, international associations, and academia.
Ensure members are informed and engaged on policy and regulatory issues impacting the consumer health product sector.
Vp, Regulatory Affairs Jobs
By Aviso Wealth At Vancouver, British Columbia, Canada
Extensive experience (minimum 12-15 years') in the wealth management industry
Strengthen and enhance compliance processes, supervisory controls, and risk management insights through technology
Delivery of key messages to senior management of Aviso, Credit Union executives and board of directors
Strong presentation skills and public speaking experience
Maintain a current and advanced knowledge of all regulations that pertain to the functions they administer and provide thought leadership
Strong and demonstrable experience in plain language writing and communication style
Regulatory Affairs Advocacy Lead
By Mondelēz International At Greater Toronto Area, Canada
Excellent organizational, analytical, project management, and communication skills
Established professional network with hands on experience and skills interacting with food industry groups; preferred
Expertise in SARA core knowledges topics (flavors, food additives, GMO, organic, dietary requirements)
Strong attention to detail with a passion to advance regulatory compliance technical skills
6-10 years of Regulatory Affairs experience (senior level, strong compliance background)
Language skills for markets of geographic oversight for communication and correct interpretation of laws and regulations
Senior Regulatory Affairs Specialist
By STEMCELL Technologies At Vancouver, British Columbia, Canada
Be a valuable member of our risk management team, contributing from a regulatory perspective to risk assessment exercises and documents
Build partnerships, internally and externally, to provide routine updates and ensure compliance with regulatory requirements
A minimum of 3 years of experience in regulatory affairs within the medical device or life sciences industry
Proven experience in compiling and submitting pre-market regulatory submissions, such as 510(k), De novo, and IVDR Technical Documentation
Collaborate with cross-functional teams to provide regulatory inputs during the design and development phase of our devices
Compile pre-market submissions, including pre-submissions, 510(k), De novo, and IVDR Technical Documentation as necessary
Quality Assurance/Regulatory Affairs Specialist (14M Mat Leave Contract)
By DIVA At Kitchener, Ontario, Canada
Support maintenance of Diva’s ISO 13485 certification and Quality Management System as a whole.
Experience in the maintenance of Quality Management Systems, e.g., ISO 13485 and FDA QSR for medical devices;
Report on performance of the QMS to top management
Proficient in MS Office applications, quality management software & tools, and the ability to learn new software as required;
Prepare, upkeep and manage FDA, Health Canada, and other worldwide regulatory submissions as well as other regulatory related documents;
Ensure compliance with applicable regulatory standards/requirements;
Coordinator, Regulatory Affairs (6 Months)
By Bausch + Lomb At Greater Toronto Area, Canada
Knowledge and understanding of regulatory submission requirements, eCTD format, and other related material.
Assist in the review of Change Controls and the determination of filing/notification requirements
Relevant administrative experience (1 year plus), preferably in the pharmaceutical industry.
Excellent organizational and verbal/written communication skills are necessary.
Circulation of Health Canada Correspondence to the team
Assist in the preparation and/or review of responses to Health Canada letters (e.g., Notice of Non-Compliance, Notice of Deficiency, and Clarifaxes)
Quality Assurance/Regulatory Affairs Associate (25-Week Opportunity)
By DIVA At Kitchener, Ontario, Canada
Understanding of ISO 13485 requirements by certification.
Strong understanding of business practices with fundamental understanding of project management methodology and administrative functions.
Support regulatory compliance/agency audit and audit related research, documentation and preparation, in accordance with business goals, regulatory compliance, and legal requirements.
Manage training profiles and training matrix for all departments.
Work with all departments to obtain an in-depth understanding of the documentation requirements.
Work in accordance with Diva International Inc.’s Quality Policy and B-Corp set of standards, ISO, GMP and FDA requirements as applicable.
Quality Assurance Regulatory Affairs Manager
By Ventripoint Diagnostics Ltd. At Greater Toronto Area, Canada
Experience preparing regulatory submissions, license applications, registrations and other product approval documentation and demonstrated knowledge of applicable requirements and practices.
Management Representative; responsible for implementation, governance, performance reporting, and maintenance of Ventripoint’s quality management system.
Ensure compliance with GMPs, and applicable regulatory requirements related to product importation, release and distribution in Canada, United States, and Europe.
Manage preparation and implementation of new SOPs. Manage CAPAs, deviations, and out-of-specification investigations.
Manage preparation and review of validation protocols and reports.
Experience developing regulatory strategies and plans.
Head Pharmaceutical Quality And Regulatory Affairs, Pni And Genomic Medicines
By Pall Corporation At Vancouver, British Columbia, Canada
In depth knowledge of regulatory requirements, i.e., GMP, Health Canada, EU, and FDA and experience with GMP documentation review.
Designing, implementing, harmonizing and systemically reviewing the Cytiva Pharma Quality Management System (QMS), starting with PNI.
Accountable for Quality Governance, Quality Escalation and Quality Management Review processes.
Manage Regulatory and Quality personnel in accordance with Company talent management practices. Train, mentor, and coach the staff within the department
Provide daily leadership and management for the teams that report into this position to drive excellence in quality related functions.
Participate in any issues that require management escalations

Are you looking for an exciting opportunity to make a real difference in the healthcare industry? We are looking for a Regulatory Affairs Officer to join our team and help us ensure that our products meet all regulatory requirements. If you have a passion for regulatory compliance and a drive to make a positive impact, this could be the perfect job for you!

Overview: Regulatory Affairs Officers are responsible for ensuring that a company’s products and services comply with all applicable laws and regulations. They work closely with other departments such as research and development, marketing, and legal to ensure that products meet the necessary standards. They also provide advice and guidance on regulatory issues, and monitor changes in the regulatory environment. How to Become a Regulatory Affairs Officer: To become a Regulatory Affairs Officer, you must have a bachelor’s degree in a related field such as biology, chemistry, or engineering. You may also need to have experience in the field, such as working in a laboratory or in a regulatory agency. Regulatory Affairs Officer Skills: Regulatory Affairs Officers must have strong analytical and problem-solving skills, as well as excellent communication and interpersonal skills. They must also be able to work independently and as part of a team. Regulatory Affairs Officer Knowledge: Regulatory Affairs Officers must have a thorough understanding of the laws and regulations that apply to their company’s products and services. They must also be familiar with the relevant industry standards and guidelines. Regulatory Affairs Officer Responsibilities: Regulatory Affairs Officers are responsible for ensuring that a company’s products and services comply with all applicable laws and regulations. They must also provide advice and guidance on regulatory issues, and monitor changes in the regulatory environment. Regulatory Affairs Officer Experience: Regulatory Affairs Officers must have experience in the field, such as working in a laboratory or in a regulatory agency. Regulatory Affairs Officer Qualifications: Regulatory Affairs Officers must have a bachelor’s degree in a related field such as biology, chemistry, or engineering. Regulatory Affairs Officer Education: Regulatory Affairs Officers must have a thorough understanding of the laws and regulations that apply to their company’s products and services. They must also be familiar with the relevant industry standards and guidelines. Tools to Help Regulatory Affairs Officer Work Better: Regulatory Affairs Officers can use software such as Microsoft Office, Adobe Acrobat, and other document management systems to help them manage their work. They can also use online databases to stay up-to-date on the latest regulations. Good Tips to Help Regulatory Affairs Officer Do More Effectively: Regulatory Affairs Officers should stay organized and keep detailed records of their work. They should also be proactive in researching new regulations and staying up-to-date on changes in the regulatory environment.

Common Regulatory Affairs Officer Interview Questions:

• What experience do you have in regulatory affairs?
• How do you stay up-to-date on changes in the regulatory environment?
• What challenges have you faced in regulatory affairs?
• How do you ensure that a company’s products and services comply with all applicable laws and regulations?
• What strategies do you use to ensure compliance?