21 Emplois pour Regulatory Affairs - Canada
Manager, Regulatory Affairs - IVD
Aujourd'hui
Emploi consulté
Description De L'emploi
Position Overview:Join a growing IVD company as Manager, Regulatory Affairs (IVD). With your 6+ years of IVD experience and RAC certification, you will lead regulatory strategies and submissions to support global market approvals for diagnostic medical devices. Responsibilities include preparing submissions (510(k), CE, Health Canada, WHO, etc.), overseeing product licensing, complaint handling, post-market surveillance, labeling, and change notifications. You will manage regulatory staff and collaborate cross-functionally with leadership, product development, and quality teams.Key Responsibilities:Regulatory Leadership:
Lead preparation and submission of global regulatory filings (e.g., De Novo, PMA, 510(k))Act as the primary liaison with regulatory agenciesManagement and mentor a regulatory teamCompliance & Strategy:
Develop and implement strategies to meet global standards (FDA, EU IVDR, Health Canada, PMDA, NMPA, HAS and TGA, etc.)Proven leadership, project management, and communication skillsMonitor regulatory changes to assess impacts on productsOversee product licensing, labeling, complaints, and post-market surveillanceCollaboration & Mentorship:
Partner with R&D, Quality, and Operations teams to ensure market readinessMentor junior staff and review work for complianceProcess Improvement:
Optimize regulatory workflows and documentation processesQualifications:Education: Bachelor’s in Life Sciences, Biotechnology, RAC preferredExperience:
Required 5+ years in Regulatory Affairs, with specific experience working in IVDs.Proven experience with global submissions (e.g. De Novo, PMA, 510(k)), Canada, Europe (IVDR), Japan, China, Singapore, Australia).Proven leadership, project management, and communication skillsAuthority to work in Canada.Perks:Competitive salary Health and dental benefits, paid sick days, birthday offFree parking, on-site gym, and a dynamic workplace cultureWhat’s Offered:This is an exciting opportunity to join a dynamic organization driving impactful diagnostic solutions.To Apply:For a full job description contact Carla Campbell, Executive Talent Consultant, TalentSphere – Life Sciences, at To apply, please use the TalentSphere job board.#TSSHP LI-TS1#LI-TS1Job Posting ID: #
Regulatory Affairs Assistant (Co-op)
Aujourd'hui
Emploi consulté
Description De L'emploi
Please note: This is a paid co-op opportunity for students currently enrolled in an academic program, available for the Winter term (January to April).
The Crump Group Inc. is a family-owned and operated premium pet treat manufacturer. Started in 2006, we have successfully established 3 market leading brands (Caledon Farms, Crumps Naturals AND Dog Delights) distributed throughout Canada and the United States. The Crump Group Inc., a large & rapidly growing pet food manufacturer based in Mississauga Ontario and Nashville North Carolina is seeking a dynamic, results Regulatory Affairs Assistant Job Overview
We are looking for a qualified Regulatory Affairs Assistant. In the position of Regulatory Affairs Assistant, provide assistance and reporting to the Director of Quality and Regulatory Affairs in all aspects of day-to-day duties to include the following:
Key Responsibilities:
- Assist in preparing, reviewing, and submitting regulatory documents for product approvals.
- Research and analyze regulatory requirements specific to (industry/region).
- Maintain and update regulatory databases and filing systems.
- Support cross-functional teams in ensuring compliance with applicable standards.
- Monitor updates to local and international regulations and communicate key changes.
- Participate in audits, inspections, and quality assurance initiatives as required.
- Provide administrative support to the Regulatory Affairs team.
Qualifications:
- Currently enrolled in a (Bachelor's/Master's) program in (Life Sciences, Pharmacy, Engineering, or related field).
- Strong interest in regulatory affairs and compliance.
- Excellent organizational skills and attention to detail.
- Strong written and verbal communication skills.
- Ability to work collaboratively in a team environment.
- Research and analyze regulatory requirements specific to the pet / animal feed industry
- Proficiency in Microsoft Office
What You’ll Gain:
- Hands-on experience with regulatory processes and documentation.
- Exposure to cross-functional collaboration in a professional setting.
- Professional development opportunities and mentorship.
The Crump Group is committed to equity in employment and diversity. The Crump Group will provide an inclusive and barrier free recruitment process to applicants with accessibility needs in accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act (AODA). If you require a disability-related accommodation during this process, please inform The Crump’s Group of your requirements.
In compliance with Ontario's Bill 190, we confirm that this posting represents a current, existing vacancy. This job description may be amended at any time.
Regulatory Affairs Consultant (Rate Applications)
Aujourd'hui
Emploi consulté
Description De L'emploi
The Regulatory Affairs Consultant will be responsible for leading detailed regulatory research, analysis and evidence development activities, engaging and collaborating with internal stakeholders on complex regulatory matters, providing regulatory advice to senior leaders and advocating for the organization’s interests through regulatory and/or energy policy proceedings. They consult with business unit stakeholders to educate the organization on the impact of regulatory policy, process and decisions, and execute departmental activities to implement the regulatory strategy, promote regulatory acumen in the organization and advance rate application objectives. The incumbent is also responsible for supporting the monitoring and reporting of rate application projects. The incumbent is expected to behave ethically and follow the established code of business conduct, policies and internal control procedures, laws and regulations governing Toronto Hydro.
KEY RESPONSIBILITIES: Conducts detailed, jurisdictional regulatory and/or energy policy research and analysis on emerging issues associated with economic regulation frameworks, integration of distributed energy resources into local grids, and evolving roles of utility companies in meeting evolving customer needs and preferences.
Proactively conducts and consolidates detailed jurisdictional research and stakeholder engagement on emerging policy issues and regulatory framework requirements to maintain regulatory compliance and identify opportunities, mitigate risks for advancement.
Represents and advances the organization’s regulatory strategy, acting as a subject matter expert.
Reviews the organization’s rate and non-rate related applications to ensure consistency in quality and content of evidence.
Develops briefing materials (slide decks, briefing notes) and generates quantitative, qualitative analysis to inform regulatory and rate applications strategy and issues management activities. REQUIREMENTS: Bachelor of Economics, Public Policy/Administration, Business Administration, Engineering or a related degree: preference will be given to a Master’s level degree in any of the above fields.
Five (5) to seven (7) years of experience of direct or indirect energy and regulatory policy matters with the Ontario Energy Board and/or the Independent Electricity System Operator (or their equivalents in other jurisdictions).
Strong understanding of the Ontario’s utility regulatory framework (and marketplace) including an understanding of relevant agencies, stakeholders, and interests.
Deep knowledge of regulatory provincial legislation, handbooks and code for electric utilities.
Knowledge of performance based regulatory theory and practice and of alternat.
Considerable experience and comfort providing briefings and generating required materials (PowerPoint, Word).
Critical thinking and problem-solving skills, including experience using Excel.
Excellent oral and written communication and advocacy skills.
Knowledge of alternative regulatory frameworks (e.g. cost of service, rate of return, incentive rate mechanism).
Knowledge and understanding of financial and operating consequences of regulatory rules, policies and proposals.
Business and financial acumen.
Knowledge of provincial and federal policy development processes.
Stakeholder management skills. This position is based in a hybrid environment allowing for remote work two days per week, based on business needs. Employees will be required to come onsite Tuesday to Thursday. You are expected to live in Ontario and within reasonable commuting distance of the office. #LI-Hybrid
Thank you for considering a career with Toronto Hydro. We welcome applications from all qualified candidates. If you’re having difficulty using our online application system and require accommodation, please email or call . Toronto Hydro is pleased to provide reasonable accommodation for qualified individuals throughout the job application process. Please note this email is for accommodation requests only. Resumes sent to this email address will not be considered. Learn more about our commitment to accessibility.
Soyez le premier informé
À propos du dernier Regulatory affairs Emplois dans Canada !