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Regulatory affairs Jobs in Pierrefonds, QC

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Regulatory affairs • pierrefonds qc

Last updated: 1 day ago
Regulatory Manager - Gestionnaire Affaires Réglementaires

Regulatory Manager - Gestionnaire Affaires Réglementaires

Cameleon RHPointe-Claire, QC, ca
Full-time +1
Quick Apply
Chez Caméléon RH, nous croyons que le bonheur au travail repose sur un bon jumelage entre le rôle, l'entreprise, le patron et l’environnement. Nous vous écoutons, vous comprenons et nous nous engage...Show moreLast updated: 4 days ago
COMPLIANCE ASSOCIATE - 002120 PRODUCTION

COMPLIANCE ASSOCIATE - 002120 PRODUCTION

Dorel IndustriesMontreal, QC, Canada
CA$55,000.00 yearly
COMPLIANCE ASSOCIATE - 002120 PRODUCTION.Montreal, QC, Canada • Virtual Req #71 Monday, July 15, 2024.The Compliance Associate is responsible for providing administrative support to the Sr.Director...Show moreLast updated: 30+ days ago
Administration Technician (Corporate Affairs)

Administration Technician (Corporate Affairs)

Vanier CollegeMontreal, QC, CA
CA$24.21–CA$32.32 hourly
Job Title : Administration Technician (Corporate Affairs) Reference number : S-23-24-3270 Job Category (Job Alert) : Administration Department : Communications & Corporate Affairs Services : Corpor...Show moreLast updated: 30+ days ago
  • Promoted
Remote Executive Assistant

Remote Executive Assistant

Randstad CanadaMontréal, Quebec, CA
CA$60,000.00–CA$70,000.00 yearly
Remote
Permanent
Quick Apply
Executive Assistant - Remote - Montreal.A professional order located near Crémazie metro station in Montreal is seeking an Executive Assistant to support the Legal Affairs Department and the Secret...Show moreLast updated: 16 days ago
Regulatory Business Analyst (Hybrid)

Regulatory Business Analyst (Hybrid)

National BankMontreal, Quebec
Full-time +2
Attendance Hybrid Job number 25261 Category Senior Professional.Permanent Type of Contract Permanent.Full-Time Full Time / Part Time? Full-Time Posting date 10-Mar-2025. Montreal, Quebec City Montre...Show moreLast updated: 5 days ago
Regulatory Affairs Associate (14-Month Contract)

Regulatory Affairs Associate (14-Month Contract)

AbbVieMontreal, Québec, Canada
Full-time +1
The ideal candidate will work from our St-Laurent, QC offices.The Regulatory Affairs (RA) Associate is responsible for supporting or leading the preparation, filing, negotiation and approval o...Show moreLast updated: 1 day ago
CMC Regulatory Project Manager - Consultant, FSP (US or Canada)

CMC Regulatory Project Manager - Consultant, FSP (US or Canada)

ParexelRemote, Quebec, Canada
Remote
When our values align, there's no limit to what we can achieve.If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we...Show moreLast updated: 22 days ago
Regulatory Associate

Regulatory Associate

International Financial GroupMontreal, Quebec
CA$33.00 hourly
Our client is seeking to augment their Broker Dealer Regulatory Reporting team with an Associate for a 6-month contract.In this capacity, the successful candidate will be responsible for addressing...Show moreLast updated: 30+ days ago
Regulatory Project Manager

Regulatory Project Manager

ExperTech RecruitingMontreal
CA$200,000.00 yearly
A large international financial services company is looking to hire a .This is a full-time position for an initial 10-month assignment, working in a hybrid environment (possibility of extension or ...Show moreLast updated: 30+ days ago
Regulatory Approvals Lead

Regulatory Approvals Lead

EnviroCareersVancouver, Victoria, Edmonton, Calgary, Toronto, Ottawa, etc, BC, Canada
CA$120,000.00–CA$150,000.00 yearly
My client is a niche environmental consulting firm specializing in environmental impact assessments, project permitting and management, regulatory engagement and approvals, indigenous stakeholder e...Show moreLast updated: 30+ days ago
Regulatory Affairs Specialist

Regulatory Affairs Specialist

CPG ConnectMontreal, CA
CA$81,410.14–CA$101,762.68 yearly
Conagra Brands is one of North America's leading brandedfood companies.We have a rich heritage of making great food, and a team that’spassionate about innovation and growth.Conagra offers choices f...Show moreLast updated: 30+ days ago
  • Promoted
Political Affairs Program

Political Affairs Program

The Borgen ProjectMontreal, QC, Canada
Full-time
Are you passionate about making a difference in the world? Look no further!.The Borgen Project is an international organization that works at the political level to improve living conditions for pe...Show moreLast updated: 24 days ago
Clinical Scientist, Director, Primary and Specialty Care

Clinical Scientist, Director, Primary and Specialty Care

PfizerMontreal,Quebec,Canada
CA$112,800.00–CA$169,200.00 yearly
Full-time
The Clinician, Clinical Scientist (CS) will provide leadership in clinical epidemiological study execution ensuring consistency of approach, conduct, result reporting and oversight of core team act...Show moreLast updated: 30+ days ago
Regulatory Counsel or Director, Legal Affairs

Regulatory Counsel or Director, Legal Affairs

PSP InvestmentsMontreal
CA$80,000.00–CA$100,000.00 yearly
Full-time
At PSP, we encourage our employees to grow, forge powerful relationships, contribute and fuel inspired investment launchpads. We are committed to a culture that fosters collaboration and allows us t...Show moreLast updated: 30+ days ago
Regulatory Affairs Project Manager

Regulatory Affairs Project Manager

CellCartaMontreal, QC, CA
Full-time
Quick Apply
Regulatory Affairs Project Manager Eager to embark on a new professional journey that will transform your career? CellCarta, a leading Contract Research Organization, is hiring a Regulatory Affairs...Show moreLast updated: 7 days ago
Manager, Regulatory Affairs

Manager, Regulatory Affairs

Innomar StrategiesRemote, Quebec
CA$151,600.00–CA$281,500.00 yearly
Remote
Full-time
Our team members are at the heart of everything we do.At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on ...Show moreLast updated: 30+ days ago
  • Promoted
Sr Regulatory Consultant

Sr Regulatory Consultant

Syneos HealthMontreal, Canada
Full-time
Description Senior Regulatory Consultant Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, med...Show moreLast updated: 30+ days ago
Francophone Affairs Commissioner

Francophone Affairs Commissioner

SSMUMontréal, Québec, Canada
CA$15.65 hourly
Francophone Affairs Commissioner.L'Association Étudiante de l'Université de McGill est présentement en période d'embauches. Avec plus de 20,000 membres, l'AÉUM a pour rôle de représenter les étudian...Show moreLast updated: 30+ days ago
Manager, Regulatory Compliance - Gas

Manager, Regulatory Compliance - Gas

Liberty UtilitiesRawdon, Quebec,
CA$95,000.00 yearly
This position may be located at any Liberty location •.This position is the owner of gas compliance maintenance plan standards and reporting, and is responsible for monitoring adherence to standards...Show moreLast updated: 30+ days ago
Manager, Lease Documentation (Legal Affairs)

Manager, Lease Documentation (Legal Affairs)

Allied Properties REITMontréal, Quebec
Full-time +1
At Allied, everything starts with purpose.In the role of Manager, Lease Documentation, you will negotiate, draft and deliver commercial leases and other ancillary agreements.Please note, our depart...Show moreLast updated: 16 days ago
Regulatory Manager - Gestionnaire Affaires Réglementaires

Regulatory Manager - Gestionnaire Affaires Réglementaires

Cameleon RHPointe-Claire, QC, ca
4 days ago
Job type
  • Full-time
  • Permanent
  • Quick Apply
Job description

Job Description

Chez Caméléon RH, nous croyons que le bonheur au travail repose sur un bon jumelage entre le rôle, l'entreprise, le patron et l’environnement.

Nous vous écoutons, vous comprenons et nous nous engageons à vous proposer des opportunités où vous pourrez vous épanouir tant professionnellement que personnellement.

Lieu :   Pointe-Claire

Type d’emploi :   Permanent

Requis essentiels  :

  • Expérience avec les réglementations 510(k) et FDA pour les dispositifs médicaux.
  • Expérience en pré-commercialisation et post-commercialisation , incluant le renouvellement des licences.
  • Minimum de 2 ans d’expérience en gestion d’équipe .

Votre rôle

En tant que Gestionnaire de la réglementation , vous dirigerez l’équipe de réglementation afin d’assurer la conformité des produits et des installations de l’entreprise en Amérique du Nord aux exigences réglementaires (FDA, Santé Canada). Vous développerez et mettrez en œuvre des stratégies réglementaires soutenant la commercialisation des produits, les objectifs commerciaux et l’expansion du marché ainsi que de maintenir / améliorer la santé des produits commercialisés et de protéger la continuité des revenus.

Principales responsabilités

Stratégie réglementaire et accent business (50%)

  • Développer et exécuter des stratégies et des plans tactiques pour soutenir la commercialisation des produits et les objectifs commerciaux. Travailler en étroite collaboration avec les groupes marketing et commerciaux.
  • Fournir des conseils règlementaires stratégiques tout au long du processus de conception et de développement afin d’assurer la conformité aux exigences FDA 510(k), Santé Canada et autres réglementations applicables.
  • Gérer les soumissions réglementaires pour les nouveaux produits, les extensions de gamme et les renouvellements afin d’obtenir les approbations nécessaires dans les délais impartis.
  • Entretenir des relations solides avec les agences réglementaires (FDA, Santé Canada), en agissant en tant que représentant de l’entreprise.
  • Assurer le renouvellement et le maintien, dans les délais prescrits, des licences réglementaires et opérationnelles des produits et installations aux États-Unis et au Canada.
  • Surveiller les tendances réglementaires et mettre en place des initiatives d’amélioration continue pour renforcer la conformité et l’efficacité.

    • Conformité opérationnelle et post-commercialisation (30%)

  • Superviser la conformité post-commercialisation, y compris les rapports et les communications avec les autorités réglementaires.
  • S’assurer du respect des exigences en matière de déclaration des événements indésirables, et former les employés aux bonnes pratiques.
  • Agir en tant que correspondant officiel en matière de réglementation pour les installations de l’entreprise et soutenir les inspections des agences réglementaires.
  • Mettre en place des améliorations de processus et une approche basée sur les risques pour garantir la conformité réglementaire tout en soutenant la croissance commerciale.

    • Leadership et développement d’équipe (20%)

  • Diriger, encadrer et développer l’équipe de réglementation pour atteindre les objectifs stratégiques de l’entreprise.
  • Encourager une culture de conformité, de responsabilisation et d’amélioration continue au sein de la fonction réglementaire.
  • S’assurer que les opérations réglementaires respectent les politiques de l’entreprise ainsi que les exigences environnementales, de santé et de sécurité.

    • Qualifications requises

    Compétences et connaissances

  • Excellente connaissance des réglementations canadiennes et américaines pour les dispositifs médicaux (FDA 510(k), Santé Canada).
  • Expérience en pré-commercialisation et post-commercialisation , y compris les renouvellements de licences.
  • Capacité à développer des stratégies réglementaires et à prendre des décisions basées sur les risques.
  • Solides compétences en leadership, communication et gestion des parties prenantes.
  • Capacité à gérer plusieurs priorités dans un environnement dynamique.

    • Expérience

  • Minimum de 8 ans d’expérience en affaires réglementaires, idéalement dans le secteur des dispositifs médicaux .
  • Minimum de 2 ans d’expérience en gestion d’équipe et en leadership en matière de conformité réglementaire.
  • Expérience avérée dans la gestion des soumissions réglementaires et les interactions avec la FDA et Santé Canada.
  • Expérience dans un environnement matriciel et en collaboration interfonctionnelle.

    • Éducation et certifications

  • Baccalauréat en ingénierie, sciences de la vie, affaires réglementaires ou discipline technique connexe.
  • Connaissance approfondie des exigences réglementaires pour les dispositifs médicaux (Canada, États-Unis).
  • Atout : Maîtrise ou certification professionnelle en affaires réglementaires, gestion de produits ou domaine connexe.

    • Ce que nous offrons

  • Rémunération et avantages compétitifs.
  • Un environnement de travail collaboratif axé sur l'apprentissage continu et le développement professionnel.
  • L'opportunité de travailler avec les meilleurs experts en réglementation du secteur.

    • Location : Pointe-Claire

    Employment Type : Full-time, permanent position

    Must-Have experience :

  • Experience with 510(k) and FDA regulations for medical devices.
  • Experience in pre-market and post-market regulatory processes, including license renewals.
  • Minimum of 2 years of managerial experience.

    • Your Role

    As a Regulatory Manager , you will lead the regulatory team to ensure compliance of the company’s products and facilities in North America with regulatory requirements (FDA, Health Canada). You will develop and implement regulatory strategies that support product commercialization, business objectives, and market expansion as well as maintain / enhance health of marketed products and protect revenue continuity.

    Your responsibilities will include :

    Key Responsibilities

    Regulatory Strategy & Business Focus (50%)

  • Develop and execute regulatory strategies and tactical plans to support product commercialization and business objectives. Work in close collaboration with marketing and commercial teams.
  • Provide strategic regulatory input throughout the design and development process, ensuring compliance with FDA 510(k), Health Canada , and other applicable regulations.
  • Manage regulatory submissions for new products, line extensions, and renewals, ensuring timely approvals.
  • Maintain and enhance relationships with regulatory agencies (FDA, Health Canada), acting as the company representative.
  • Ensure the timely renewal and maintenance of regulatory and operating licenses for products and facilities in the U.S. and Canada.
  • Monitor regulatory trends and implement continuous improvement initiatives to enhance compliance and efficiency.

    • Operational & Post-Market Compliance (30%)

  • Oversee post-market regulatory compliance, including timely reporting and communication with regulatory authorities.
  • Ensure compliance with adverse event reporting requirements, training employees on proper procedures.
  • Act as the official regulatory correspondent for the company’s facilities and support inspections by regulatory agencies.
  • Implement process improvements and risk-based approaches to ensure regulatory compliance while enabling business growth.

    • Team Leadership & Development (20%)

  • Lead, mentor, and develop the regulatory team to align with Medicom’s strategic objectives.
  • Foster a culture of compliance, accountability, and continuous improvement within the regulatory function.
  • Ensure regulatory operations align with company policies, environmental, health, and safety requirements.

    • Required Qualifications

    Skills & Knowledge

  • Strong knowledge of U.S. and Canadian medical device regulations (FDA 510(k), Health Canada).
  • Experience in pre-market and post-market regulatory processes , including license renewals.
  • Strategic thinking and risk-based decision-making in regulatory affairs.
  • Excellent leadership, communication, and stakeholder management skills.
  • Ability to manage multiple priorities in a fast-paced environment.

    • Experience

  • Minimum of 8 years of experience in regulatory affairs, preferably in the medical device industry .
  • Minimum of 2 years of experience in team management and regulatory compliance leadership.
  • Proven track record in regulatory submissions and interactions with FDA and Health Canada.
  • Experience in a matrix organization and cross-functional collaboration.

    • Education & Certifications

  • Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related technical discipline.
  • Advanced knowledge of regulatory requirements for medical devices (Canada, U.S.).
  • As an asset : Master’s degree or professional certification in regulatory affairs, product management, or a related field.

    • 6 Great Reasons to Apply :

  • Competitive salary .
  • Comprehensive insurance program , including EAP and telemedicine for you and your family.
  • Company-matched retirement plan .
  • Numerous training, coaching, and professional development opportunities .
  • A friendly and dynamic work atmosphere , with social events, sports, BBQs, and more!

    • Pssst… Looking for a new opportunity but unsure if this one is the right fit?

    Feel free to send us a spontaneous application at [email protected] !

    And if you know someone who would be a great match, don’t hesitate to refer them to us!