Spécialiste, Affaires Réglementaires Pré-Commercialisation / Pre-Market Regulatory Affairs Specialist

Cameleon RH
India
$55K a year (estimated)
Permanent
Full-time

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.
  • 2 days ago
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