Regulatory Compliance Specialist
7 days ago
**About Vitalbio**
Vitalbio is revolutionizing the landscape of point-of-care diagnostics with our groundbreaking platform, VitalOne. Our mission is to make healthcare more accessible and proactive.
We have built a dynamic team of experts across various disciplines including chemistry, software, engineering, and microfluidics.
This role is for a Quality Assurance Documentation Manager who will be responsible for administering the Electronic Document Management System and Learning Management System.
The ideal candidate will ensure that document management and training programs are implemented and effectively administered while maximizing efficiency, complying with industry standards, and achieving compliance targets.
Key Responsibilities:
- Create and maintain documentation associated with the production of medical devices as per ISO 13485 and relevant regulatory requirements;
- Provide multi-departmental support related to product development and documentation;
- Control the release of design and process documents through an electronic quality management system (eQMS);
- Maintain documents that record the status of equipment used in the design, development, and manufacturing of medical devices;
- Liaise with stakeholders regarding document approvals;
- Maintain and report on performance metrics for Document Control and Training.
Requirements:
- Bachelor's degree in Science or Engineering;
- 1+ years of work experience in a QA function in an ISO 9001 or ISO 13485-certified environment;
- Excellent English written and oral communication skills;
- Experience managing electronic and paper quality management systems, document control systems, and learning management systems;
- Previous experience in current Good Manufacturing Practices (cGMP) quality guidelines and FDA regulations including 21 CFR Part 11 and ISO 13485 requirements;
- Strong communication skills and ability to work cross-functionally to problem solve and improve processes and procedures;
- Ability to effectively work within a fast-paced team environment;
- Strong attention to detail, able to execute aggressive timelines;
- Good interpersonal skills with the ability to interact with people at all levels with sensitivity and tact.
-
Compliance and Regulatory Specialist
3 days ago
Oakville, Ontario, Canada SteriMax Inc. Full timeSteriMax Inc. is seeking a skilled Compliance and Regulatory Specialist to join our regulatory affairs team. In this role, you will be responsible for building and maintaining a healthy working relationship with business partners, executing labelling activities, and contributing to an efficient and effective regulatory affairs team.Responsibilities:Business...
-
Compliance and Regulatory Specialist
2 days ago
Oakville, Ontario, Canada Emterra Group Full timeRyse Solutions is a leading Canadian Producer Responsibility Organization dedicated to helping companies fulfill their Extended Producer Responsibility (EPR) regulatory obligations. We strive to create regenerative solutions that empower people and businesses in the development of a sustainable future.">The Compliance and Reporting Specialist is responsible...
-
Regulatory Compliance Specialist
18 hours ago
Oakville, Ontario, Canada Odgers Berndtson Full timeJob Summary:We are seeking an experienced Accountant II to join our Registration, Inspections & Examinations (RIE) Branch. The successful candidate will be responsible for conducting reviews of registered firms and regulated entities to assess compliance with Ontario securities laws, and for preparing reports detailing non-compliance with securities laws and...
-
Compliance Specialist
7 days ago
Oakville, Ontario, Canada Emterra Group Full timeRyse Solutions is a leading Canadian producer responsibility organization dedicated to helping companies fulfill their extended producer responsibility (EPR) obligations and sustainability goals. Our mission is to create regenerative solutions that empower people and businesses in the development of a sustainable future.Job SummaryThe Compliance and...
-
Regulatory Affairs Manager
7 days ago
Oakville, Ontario, Canada Emterra Group Full timeAt Ryse Solutions, we are committed to creating regenerative solutions that promote a culture of compliance and mitigate risks associated with non-compliance. As a Compliance and Reporting Specialist, you will play a critical role in ensuring our company's adherence to EPR regulations and industry standards.Job DescriptionThis role involves developing and...
-
Associate, Regulatory and Compliance
3 days ago
Oakville, Ontario, Canada SteriMax Inc. Full timeWe are looking for an experienced Associate, Regulatory and Compliance professional to join our team at SteriMax Inc. In this role, you will be responsible for evaluating and ensuring that submissions are accurate and meet format and content requirements as per Health Canada regulations, completing dossier publishing using eCTD software.Responsibilities:RA...
-
Tax Compliance Specialist
5 days ago
Oakville, Ontario, Canada Samuel Packaging Systems Group Full timeJob OverviewWe are seeking a highly skilled Tax Compliance Specialist to join our team at Samuel. The ideal candidate will have strong knowledge of Canadian tax regulations and excellent analytical skills.ResponsibilitiesManage tax compliance: Oversee all aspects of tax compliance, including the preparation and filing of corporate income tax returns and...
-
Regulatory Affairs Specialist
4 days ago
Oakville, Ontario, Canada SteriMax Inc. Full time**Job Summary:**SteriMax Inc. is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for preparing regulatory submissions for generic drug products and actively participating in the management of submissions under regulatory agency review.Key Responsibilities:Provide...
-
Regulatory Affairs Coordinator
2 days ago
Oakville, Ontario, Canada Emterra Group Full timeAt Ryse Solutions, we're dedicated to driving sustainability through Producer Responsibility. Our team develops innovative solutions to help businesses meet their Extended Producer Responsibility (EPR) obligations.">The Compliance and Reporting Specialist plays a critical role in ensuring our company's compliance with the Resource Recovery and Circular...
-
Environmental Compliance Manager
2 days ago
Oakville, Ontario, Canada Emterra Group Full timeRyse Solutions is a pioneering Canadian organization driving sustainability through Producer Responsibility. Our team strives to create innovative solutions empowering businesses to meet their Extended Producer Responsibility (EPR) obligations.">The Compliance and Reporting Specialist will oversee our company's compliance with the Resource Recovery and...
-
Regulatory Affairs Associate
3 days ago
Oakville, Ontario, Canada SteriMax Inc. Full timeAt SteriMax Inc., we are seeking a highly motivated and detail-oriented Regulatory Affairs Associate to join our team. As a key member of our regulatory affairs team, you will be responsible for preparing regulatory submissions for generic drug products and actively participating in the management of submissions under regulatory agency review.Key...
-
Corporate Compliance Specialist
2 days ago
Oakville, Ontario, Canada Phoenix Search Group Inc. Full timePhoenix Search Group Inc. is looking for a Corporate Compliance Specialist to join our team. As a critical component of our organization, you will be responsible for providing management with effective advice concerning corporate/commercial agreements, legal compliance, business strategy, risk, and privacy issues.Responsibilities:You will work closely with...
-
Accountant Regulatory Affairs
10 hours ago
Oakville, Ontario, Canada Odgers Berndtson Full timeAbout the Team:The Registration, Inspections & Examinations (RIE) Branch is a multidisciplinary team consisting of professional staff (accountants and lawyers), registration officers, and support staff. We are responsible for overseeing the crypto-asset trading platforms, dealers, advisers, and investment fund managers that the public relies on when...
-
Compliance and Governance Leader
11 hours ago
Oakville, Ontario, Canada Phoenix Search Group Inc. Full timeKey ResponsibilitiesThe Chief Risk Officer/Risk and Compliance Manager/Compliance and Governance Leader will oversee Risk and Compliance, combining expertise in regulatory compliance and risk management to ensure the organization operates within legal frameworks while mitigating potential risks.Responsibilities include:Developing, implementing, and...
-
Associate, Regulatory Affairs
3 days ago
Oakville, Ontario, Canada SteriMax Inc. Full time2770 Portland DriveOakville, ON L6H6R4, CANDescriptionPosition Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Oakville, OntarioPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to...
-
Tax Compliance Specialist
2 days ago
Oakville, Ontario, Canada WellStat Full timeOverview of WellStat">We are a leading provider of real-time energy management and wellness solutions. Our mission is to create healthier and more profitable buildings for our clients by offering innovative products and services.Our core product includes Demand Response Management, Energy Management Software, and commercial Indoor Air Quality (IAQ)...
-
Oakville, Ontario, Canada Geotab Inc. Full timeWe are a company of diverse and talented individuals who work together to help businesses grow and succeed, and increase the safety and sustainability of our communities.As a Senior Information Security, Compliance & Risk Specialist, you will support the development of information security policies to achieve Geotab's security goals, provide technical drafts...
-
Manager Risk and Compliance
2 weeks ago
Oakville, Ontario, Canada Phoenix Search Group Inc. Full timeThis role will oversee Risk and Compliance, however you MUST, Have a strong background in RISK management and you MUST come from Banking, Financial Services, all other industries will not be considered a fit for this role.It is a Contract role, 12 monthswe work 3 days in office, Tues and Thurs are mandatorySalary is 110 K, no benefits and no bonus.As a...
-
Manager Risk and Compliance
24 hours ago
Oakville, Ontario, Canada Phoenix Search Group Inc. Full timeThis role will oversee Risk and Compliance, however you MUST, Have a strong background in RISK management and you MUST come from Banking, Financial Services, all other industries will not be considered a fit for this role. It is a Contract role, 12 months we work 3 days in office, Tues and Thurs are mandatory Salary is 110 K, no benefits and no bonus. ...
-
Health Canada Regulatory Expert
4 days ago
Oakville, Ontario, Canada SteriMax Inc. Full time**Job Requirements:**To succeed in this role, you will need to have a strong understanding of regulatory affairs principles and practices, as well as excellent communication and interpersonal skills. You will also need to be able to work independently and as part of a team, with a high level of accuracy and attention to detail.Responsibilities:*Prepare...