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Regulatory affairs Jobs in Dollard-Des Ormeaux, QC

Last updated: 2 days ago
Pre-Market Regulatory Affairs Specialist

Pre-Market Regulatory Affairs Specialist

Cameleon RHPointe-Claire, QC, ca
Full-time +1
Quick Apply
Spécialiste, Affaires Réglementaires Pré-Commercialisation.Chez Caméléon RH, nous croyons au bonheur au travail et ceci passe essentiellement par un bon jumelage entre le bon rôle, la bonne entrepr...Show moreLast updated: 5 days ago
  • Promoted
Conseiller(ère) ou Directeur(trice) en chef – réglementation, Affaires juridiques / Regulatory Counsel or Director, Legal Affairs

Conseiller(ère) ou Directeur(trice) en chef – réglementation, Affaires juridiques / Regulatory Counsel or Director, Legal Affairs

AURAYLaval, Qc
Conseiller(ère) ou Directeur(trice) en chef – réglementation, Affaires juridiques.A PROPOS DE PSP ET DE LEUR ÉQUIPE.Notre client PSP est un des plus grands gestionnaires de fonds pour des caisses d...Show moreLast updated: 9 days ago
Advisor, Government Affairs (Ottawa Site)

Advisor, Government Affairs (Ottawa Site)

BombarbierDorval, Québec, CA, H4S 1Y9
CA$20.00–CA$24.00 hourly
When applicable, Bombardier promotes flexible and hybrid work policies.At Bombardier, we design, build and maintain the world’s peak-performing aircraft for the world’s most discerning people and b...Show moreLast updated: 30+ days ago
Assistant(e) administratif(ve), Affaires Médicales (Contrat de 14 mois- Remplacement du congé de maternité / Medical Affairs Administrative Assistant (14 Months contract- Maternity Leave Replacement)

Assistant(e) administratif(ve), Affaires Médicales (Contrat de 14 mois- Remplacement du congé de maternité / Medical Affairs Administrative Assistant (14 Months contract- Maternity Leave Replacement)

OrganonCAN - Quebec - Kirkland
CA$22.50 hourly
Full-time
L' Assistant(e) administratif(ve) aux affaires médicales est responsable d'assurer une coordination administrative, tactique et stratégique complète et de gérer le bureau pour soutenir l'équipe des...Show moreLast updated: 30+ days ago
  • Promoted
Biostatisticien Senior FSP, Phase Tardive (Senior Biostatistician)

Biostatisticien Senior FSP, Phase Tardive (Senior Biostatistician)

IQVIA LLCKirkland, Montreal (administrative region), Canada
Full-time
Biostatisticien Senior FSP, Phase Tardive (Senior Biostatistician).Data Sciences Staffing Solutions, DS3, is a unit within IQVIA that provides our sponsors with fully embedded resources through a F...Show moreLast updated: 12 days ago
Medical Science Liasion (Quebec / Atlantic)

Medical Science Liasion (Quebec / Atlantic)

AstraZenecaRemote, Quebec
CA$48.06–CA$54.91 hourly
Full-time
Medical Science Liaison (Hematology / Nephrology) – Quebec / Atlantic.Quebec / Atlantic (Field Based Role).Medical Director, Medical Affairs Canada. The Medical Science Liaison (MSL) is field based scient...Show moreLast updated: 30+ days ago
Gestionnaire, Cycle de Vie des Produits- Product Lifecycle Manager

Gestionnaire, Cycle de Vie des Produits- Product Lifecycle Manager

Medicomp IncPointe-Claire
CA$80,000.00–CA$100,000.00 yearly
Permanent
Pourquoi se joindre à notre équipe ?.Medicom est une entreprise bien établie, en pleine croissance, qui offre un environnement de travail stimulant. Nous recherchons des talents exceptionnels pour r...Show moreLast updated: 30+ days ago
Gender Advisor

Gender Advisor

Cuso InternationalLaval, QC
Full-time
This Volunteer Placement is Located in : .Please submit a Spanish Resume and Statement of Interest.Eligibility : Open to Canadian Citizens and Permanent Residents of Canada only.If you want to be part...Show moreLast updated: 6 days ago
Head of Department - Regulatory Department

Head of Department - Regulatory Department

OcéanQuébec, CA
CA$48,000.00–CA$55,000.00 yearly
ARE YOU LOOKING TO JOIN A GREAT COMPANY WHERE YOUR CONTRIBUTION WILL BE RECOGNIZED?.READ ON, THIS OFFER IS PERFECT FOR YOU!. We are actively seeking a Head of Department – Regulatory Department who ...Show moreLast updated: 30+ days ago
  • Promoted
Senior Manager, Clinical Supply Chain Management

Senior Manager, Clinical Supply Chain Management

Ventus TherapeuticsGreater Montreal, QC, Canada
Full-time
Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challengin...Show moreLast updated: 10 days ago
  • Promoted
Laboratory QA Manager - Pharma GMP

Laboratory QA Manager - Pharma GMP

Pathogenia LabGreater Montreal Metropolitan Area, Canada
Pathogenia Laboratory is a leading analytical laboratory, certified to GMP by Health Canada.We specialize in delivering high-quality analytical testing services, ensuring compliance with regulatory...Show moreLast updated: 29 days ago
  • Promoted
Director of Payments and Cards Operations

Director of Payments and Cards Operations

BrainFinanceGreater Montreal Metropolitan Area, Canada
Full-time
BrainFinance is a leading financial technology company that provides responsible and constructive credit solutions to consumers. We are redefining access to credit through our revolutionary technolo...Show moreLast updated: 3 days ago
Regulatory Affairs Specialist - CMC

Regulatory Affairs Specialist - CMC

Bausch & LombLaval, Canada
CA$55,000.00 yearly
Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness...Show moreLast updated: 30+ days ago
Manager, Patient Affairs

Manager, Patient Affairs

ServierLaval, Quebec, CA, HT S
Servier Canada, with its main office located in Laval, Quebec is a subsidiary of the Servier Research Group, a private international pharmaceutical company governed by a foundation, with its headqu...Show moreLast updated: 21 days ago
Legal Counsel (Temporary - 12 months)

Legal Counsel (Temporary - 12 months)

TransatDorval, QC, CA
CA$104,351.00–CA$132,835.00 yearly
Our mission is to be the preferred airline of our customers and our team.Open-mindedness, care for others, intelligence at work and, above all, a healthy dose of fun enable us to achieve great thin...Show moreLast updated: 30+ days ago
Medical Science Liaison, Oncology - Western Canada

Medical Science Liaison, Oncology - Western Canada

TakedaCAN, Remote
CA$48.06–CA$54.91 hourly
Remote
Full-time
With around 30,000 people working in approximately 70 countries, we are a truly global partner for better health.Takeda is dedicated to pharmaceutical innovation and tackling diseases for which the...Show moreLast updated: 30+ days ago
Sr Local Study Associate Director

Sr Local Study Associate Director

ParexelRemote, Quebec, Canada
Remote
Full-time
When our values align, there's no limit to what we can achieve.Parexel FSP is looking for a Local Study Associate Director / Senior Local Study Associate Director! This is a full-time remote position...Show moreLast updated: 2 days ago
Oncology Clinical Research Associate - Canada -

Oncology Clinical Research Associate - Canada -

ScimegaLaval, Quebec
CA$46,147.00 yearly
Under the direction of the Director, Clinical and Scientific Affairs, the CTL is responsible for execution of clinical trials, from the site selection, start-up and enrollment phases up to the stud...Show moreLast updated: 30+ 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
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
Pre-Market Regulatory Affairs Specialist

Pre-Market Regulatory Affairs Specialist

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

Job Description

English is below

Spécialiste, Affaires Réglementaires Pré-Commercialisation

Chez Caméléon RH, nous croyons au bonheur au travail et ceci passe essentiellement par un bon jumelage entre le bon rôle, la bonne entreprise, le bon patron et l’environnement qui sera stimulant pour vous! Nous sommes là pour vous écouter, vous comprendre et connaître la personne derrière le curriculum vitae. Nous nous engageons à vous présenter des offres qui vous permettront de vous épanouir et de vous réaliser en tant que professionnel, mais aussi en tant qu’individu.

Êtes-vous prêt pour l’aventure Caméléon? Notre expertise, vos couleurs!

Location  :   Pointe-Claire.

Type d’emploi  :    Le poste est permanent temps plein.

Ton environnement de travail  :

À la recherche d'une opportunité dans une grande entreprise où l'environnement de travail est rapide, dans laquelle de grands projets se trament?

Ton quotidien, en quelques lignes :

En tant que Spécialiste des affaires réglementaires avant commercialisation, vous contribuerez au succès des nouvelles offres de produits en développant / exécutant la stratégie réglementaire et les plans tactiques réglementaires tout au long du processus de conception et de développement, ainsi qu'en assurant l'enregistrement des nouveaux produits dans les délais et avec succès.

Votre participation active à des équipes interfonctionnelles ainsi que le développement d'une relation de travail étroite avec les autorités sanitaires (États-Unis, Canada, Europe) et les parties prenantes internes seront essentiels à votre réussite.

  • Élaborer et mettre en œuvre la stratégie et les plans tactiques en matière de réglementation avant la mise en marché;
  • Fournir des informations réglementaires stratégiques tout au long du processus de contrôle de la conception des dispositifs médicaux;
  • Préparer le dossier technique / les résumés du dossier technique pour les nouveaux produits conformément aux exigences des États-Unis, du Canada et de l'Europe;
  • Communiquer rapidement aux parties prenantes internes tout risque lié aux produits ainsi que toute modification de la réglementation concernant les nouveaux produits ou les offres d'extension de gamme;
  • Participer à des projets d'amélioration des processus et des outils;
  • Contribuer à la création de spécifications techniques de production et de documents techniques contrôlés similaires / liés aux produits.

La petite liste des indispensables   :

  • Licence en ingénierie, sciences de la vie, qualité / réglementation ou discipline technique connexe;
  • Au moins deux ans d'expérience en affaires réglementaires dans un environnement BPF (bonnes pratiques de fabrication), de préférence dans le domaine des dispositifs médicaux;
  • Connaissance des exigences réglementaires applicables aux dispositifs médicaux (objectif principal), aux produits de santé naturels et aux médicaments (Canada, États-Unis et Europe) et expérience à travailler avec les agences de réglementation;
  • Expérience en gestion de projets et en coordination de multiples tâches et projets parallèles dans des délais définis et / ou serrés;
  • Bilinguisme (français et anglais);
  • Compétences stratégiques, esprit critique fondé sur le risque, compétences analytiques et approche axée sur les résultats;
  • Solides compétences en matière de communication et capacité à interagir et à influencer.
  • Bonnes raisons pour postuler   :

  • Rémunération compétitive assortie d'un régime de pension;
  • Vous rejoindrez une équipe dynamique et diversifiée où votre impact sur la perception de l'entreprise sera valorisé et où vous pourrez contribuer au développement individuel et à la succession au sein de l'organisation.
  • Pre-Market Regulatory Affairs Specialist

    At Caméléon RH, we believe in happiness at work, and that means matching the right role with the right company, the right boss and the right environment to keep you energized! We're here to listen, understand and get to know the person behind the resume. We're committed to presenting you with offers that will enable you to grow and realize your full potential, not only as a professional, but also as an individual. Are you ready for the Caméléon adventure?

    Location :  Pointe-Claire.

    Type of

    position :   Permanent and full time.

    Your work environment

    Are you looking for an opportunity in a large company where the work environment is fast-paced and there are major projects in the works?

    Your day-to-day :

    As Pre-Market Regulatory Affairs specialist you will contribute to the success of new product offerings by developing / executing the regulatory strategy and regulatory tactical plans throughout the design and development process as well as by ensuring the timely and successful registration of new products.

    Your active participation in cross-functional teams as well as developing a close work relationship with health authorities (US, Canada, Europe) and internal stakeholders will be critical to your success.

  • Develop and execute the pre-market regulatory strategy and tactical plans;
  • Provide strategic regulatory input throughout the design control process of medical devices;
  • Prepare the technical file / technical file summaries for the new products as per US, Canada and European requirements;
  • Communicate promptly to internal stakeholders any product-related risks as well as any changes in regulations with respect to new product or line-extension offerings;
  • Participate in projects involving process improvements / tools;
  • Support the creation of technical production specifications and similar / related controlled technical product documentation.
  • A short list of essentials :

  • Bachelor’s degree in engineering, life sciences, quality / regulatory or related technical discipline;
  • Minimum of 2 years experience in Regulatory Affairs in a GMP (Good Manufacturing Practices) environment, preferably in medical devices;
  • Knowledge of regulatory requirements for medical devices (primary focus), natural health products and drug products (Canada, US and Europe) and experience in dealing with regulatory agencies;
  • Experience in project management and coordination of multiple parallel tasks and projects within defined and / or tight timelines;
  • Bilingualism (French and English);
  • Strategic skills, risk-based critical thinking, and analytical skills and a results-driven approach;
  • Strong communication skills with the ability to interact and influence.
  • Good reasons to apply :

  • Competitive compensation with pension plan;
  • You'll join a dynamic and diverse team where your impact on the company's perception will be valued, and where you can contribute to individual development and succession within the organization.
  • Requirements

    regulatory affairs medical device