Career Opportunities

Responsibilities:

• Prepare complex submissions including amendments and initial applications to Health Canada (e.g. MDL/MDEL), US FDA, and submissions to other regulatory agencies.
• Leads all materials required in submissions, license renewal and annual registrations.
• Directs or performs coordination and preparation of document packages for regulatory submissions.
• Keeps abreast of regulatory procedures and changes
• Responsible for the timely completion of regulatory submissions and applications and related amendments.
• Assist with preparations for Health Canada interactions and requests for general information and maintain a good relationship with it
• Ensure all regulatory records/documents are properly and adequately maintained in accordance with regulatory requirements and internal processes.
• Ensure compliance with government regulations by providing Health Canada with all necessary technical information relating to changes or modifications to regulated medical products and services.

Must Haves:

• Experience in applying MDL Health Canada or FDA in the diagnostics industry.
• Experience in applying for Scientific Research and Experimental Development (SR&ED) and Industrial Research Assistant Program (IRAP).
• Able to work in Vancouver area.

Qualifications:

• Bachelor™s degree in a life sciences discipline.
• Minimum of 1-year experience in the preparation and filing of regulated medical product applications.
• Strong problem solving and organizational skills and able to work with minimum supervision.
• Direct experience in medical devices registration and biotech regulatory affairs.
• Specialized knowledge: Knowledge of country-specific regulatory requirements (e.g. ISO 13485 / 9001, FDA, Health Canada, European IVD device regulations, etc.).
• Excellent technical and scientific report writing skills.
• Strong ability to analyze technical documents, processes, regulations, industry standards, and procedures.
• Proficient computer application skills including Microsoft Office and Google Suite
• High attention to detail with accuracy and quality

Bonus Qualifications:

• Working knowledge of the fundamentals of Canadian regulatory legislation and guidance documents.
• Ph.D. is an asset.

Responsibilities: 

• Provides administrative support to ensure efficient operation of the office
• Answers phone calls, schedules meetings and supports visitors
• Filing forms and documents
• Sending invoices and collecting receipts
• Exhibits polite and professional communication via phone, e-mail, and mail
• Maintains supplies inventory by checking stock to determine inventory level, anticipating needed supplies, placing and expediting orders for supplies

Qualifications: 

• Previous experience in Medical/Health Supplies
• Basic understanding of COVID-19 rapid antigen and antibodies test kits
• Proficiency in word processing software and Google Suite
• Ability to prioritize and manage time effectively
• Excellent communication skills
• Detail-oriented

Bonus Qualifications:

• Previous experience in similar positions

Responsibilities:

• Interact with internal and external customers daily through clear and concise written and oral communication.
• Managing inventory by keeping records of available products
• Monitor and track customer orders to meet material lead times and ensure on-time delivery.
• Resolve sales order issues, such as tax validations, and delivery issues such as tracking
• Processing sales transactions and sales contracts and receiving payments
• Ensuring that customers are fully satisfied with the services offered

Qualifications:

• Previous experience in Medical/Health Supplies in your country and familiar with the latest government regulations
• Basic understanding of COVID-19 rapid antigen and antibodies test kits
• Previous experience in Sales/Marketing
• Ability to prioritize and manage time effectively
• Strong problem-solving skills
• Excellent communication skills
• Detail-oriented

Bonus Qualifications:

• Previous experience in international trade (with Canada)

Responsibilities:

• Managing inventory by keeping records of available products
• Monitor and track customer orders to meet material lead times and ensure on-time delivery
• Interact with internal and external customers daily through clear and concise written and oral communication.
• Resolve sales order issues, such as tax validations, and delivery issues such as tracking
• Processing sales transactions and sales contracts and receiving payments
• Ensuring that customers are fully satisfied with the services offered

Qualifications:

• Basic understanding of COVID-19 rapid antigen and antibodies test kits
• Ability to prioritize and manage time effectively
• Strong problem-solving skills
• Excellent communication skills
• Detail-oriented

Bonus Qualifications:

• Previous experience in Sales/Marketing
• Previous experience in Medical/Health Supplies

Responsibilities:

• Design, monitor, and track HR metrics for the KPI dashboard including collecting and analyzing data for trends and providing recommendations.
• Create and execute multi-channel strategies to source candidates.
• Monitor changes in the regulatory environment and recommend revisions to ensure policies and programs meet changing requirements.
• Design and implement HR programs and processes in the areas of performance management, harassment, attendance management, HR policies, employment equity, employee engagement, etc.
• Research/gather and analyze data and provide recommendations to support program and policy design or enhancements.
• Assist managers and employees in effectively applying HR policies and programs to ensure consistency in interpretation and application.
• Assist with educating leadership teams on effective performance management practices.
• Identify and implement continuous improvement strategies.

Qualifications:

• University degree or college diploma in Human Resources.
• A minimum of 2-year work experience in a human resources generalist role.
• Knowledge of HR practices and principles, especially the design and implementation of the KPI dashboard.
• Experience consulting, coaching and supporting business leaders throughout the employee lifecycle (performance management, employee relations, etc.).
• Strong interpersonal, relationship-building, and influencing skills.
• Ability to work independently and within a team in a fast-paced rapidly changing environment.
• Demonstrated business acumen and consulting skills.
• Advanced knowledge of Google suite and Microsoft office.

Bonus Qualifications:

• CHRP designation or in progress.

Responsibilities:

• Providing accurate, relevant, and timely advice on legal topics that relate to health/medical devices and their products or services
• Drafting, reviewing, and negotiating various commercial contracts and agreements
• Managing and mitigating legal risks by designing and implementing company policies and procedures
• Ensuring compliance with all laws and regulations that apply to the business Promoting legal, compliance, and risk management best practices throughout the company
• Communicating with and managing any third-party bodies such as external counsel or auditors
• Staying up-to-date with changes to legislation, particularly in relation to laws, rules, and regulations that directly affect the healthcare and medical industry

Qualifications:

• Law Degree Required
• Good knowledge of Health and Medical Devices law
• Very good command of English language (other language/s an advantage)
• Ability to work independently and cooperate with different teams
• Excellent analytical skills with the capacity of identifying all risks and proactively choosing the best solutions

Bonus Qualifications:

• Basic understanding of COVID-19 rapid antigen and antibodies test kits
• Previous experience in Medical/Health Supplies