Job Description *** The English version of this job posting is available below. *** Spcialiste associ(e) Affaires rglementaires Faites partie de l''aventure Camlon! Chez Camlon , nous croyons que le bonheur au travail passe par un bon jumelage entre la bonne personne, le bon rle, la bonne entreprise et le bon gestionnaire .

Notre mission est de vous accompagner vers un environnement o vous pourrez voluer, apprendre et vous raliser autant sur le plan professionnel que personnel.

Aujourd''hui, nous recrutons pour notre client, Medicom , un chef de file reconnu dans le domaine des solutions de prvention et de contrle des infections.

Prsente l''chelle internationale, Medicom dveloppe et fabrique des produits essentiels qui contribuent protger les professionnels de la sant et les communauts partout dans le monde.

Votre quotidien ? Localisation: Pointe-Claire.

Poste hybride , offrant une belle flexibilit entre le tltravail et la collaboration en quipe. ? Type d''emploi Permanent Temps plein Un environnement o vous pourrez voluer En joignant Medicom , vous intgrerez une quipe passionne des Affaires rglementaires et de la Qualit, reconnue pour son expertise et sa collaboration.

Vous contribuerez au dveloppement et au maintien de la conformit de dispositifs mdicaux distribus travers l''Amrique du Nord et les marchs internationaux, tout en ayant l''occasion d''approfondir vos connaissances auprs de professionnels expriments.

Sous la supervision du gestionnaire des Affaires rglementaires, vous participerez activement aux diffrents projets rglementaires qui soutiennent la croissance de l''entreprise.

Vos principales responsabilits Au quotidien, vous aurez l''occasion de: Participer aux activits rglementaires lies aux produits commercialiss en Amrique du Nord.

Collaborer aux projets de dveloppement de nouveaux produits en soutenant la prparation et le suivi de la documentation rglementaire.

Contribuer aux enregistrements de produits et d''tablissements ainsi qu''au renouvellement des licences.

Effectuer la rvision et le suivi des tiquetages afin d''assurer leur conformit rglementaire.

Participer aux activits de surveillance post-commercialisation, incluant les valuations rglementaires, la documentation de vigilance et le soutien aux rappels de produits.

Rpondre aux demandes rglementaires provenant des quipes commerciales, des clients et des partenaires internationaux.

Participer la prparation de la documentation ncessaire lors d''audits et d''inspections rglementaires.

Collaborer l''amlioration continue des processus rglementaires.

Veiller au respect des exigences rglementaires applicables, notamment celles de la FDA, d''Health Canada, de l''ISO 13485, du rglement europen MDR ainsi que des autres normes pertinentes.

Contribuer la qualit de la documentation technique et des dossiers rglementaires tout au long du cycle de vie des produits.

La liste des indispensables Nous aimerions vous rencontrer si vous possdez: Baccalaurat en sciences de la vie, gnie, affaires rglementaires, qualit ou dans un domaine connexe.

De 1 3 annes d''exprience en affaires rglementaires dans l''industrie des dispositifs mdicaux ou dans un environnement fortement rglement.

Exprience avec la documentation rglementaire, les enregistrements de produits, les soumissions rglementaires ou les activits post-commercialisation.





Bonne comprhension des exigences rglementaires telles que FDA QSR/QMSR , ISO 13485 , Health Canada , EU MDR ou autres rglementations applicables.

Excellentes habilets organisationnelles et grand souci du dtail.

Capacit grer plusieurs dossiers simultanment tout en respectant les chanciers.

Esprit d''quipe, autonomie et excellentes aptitudes en communication.

Une certification ou une formation complmentaire en affaires rglementaires constitue un atout.

Disponibilit pour des dplacements occasionnels (moins de 5 % du temps). 6 bonnes raisons de postuler! Un poste permanent offrant un mode de travail hybride.

L''occasion de dvelopper votre expertise au sein d''un leader international du secteur mdical.

Des projets stimulants qui contribuent directement la sant et la scurit des communauts.

Une quipe collaborative qui favorise le dveloppement professionnel et le partage des connaissances.

Un environnement qui valorise l''innovation, l''amlioration continue et l''excellence.

Assurances mdicales et dentaires Envie de relever le dfi? Vous souhaitez mettre vos comptences au service d''une entreprise dont la mission a un impact rel sur la sant des gens? Medicom pourrait tre votre prochaine destination professionnelle! Faites-nous parvenir votre candidature ds aujourd''hui.

Et si ce poste ne correspond pas parfaitement vos aspirations, n''hsitez pas communiquer avec l''quipe Camlon .

Nous sommes toujours la recherche de nouveaux talents et serons heureux de vous accompagner vers votre prochaine opportunit professionnelle.

Au plaisir de vous rencontrer! ---------------------------------------------------------------------------------- Associate Regulatory Affairs Specialist Be Part of the Cameleon Adventure! At CameleonHR, we believe that happiness at work comes from finding the right match between the right person, the right role, the right company, and the right manager.

Our mission is to help you find an environment where you can grow, learn, and thriveboth professionally and personally.

Today, we are recruiting on behalf of our client, Medicom , one of the world''s leading manufacturers and distributors of high-quality single-use infection prevention and control products for the medical, dental, industrial, veterinary, laboratory, and health & beauty sectors.

If you''re looking to grow within an creative company where quality, compliance, and continuous improvement are at the heart of everything they do, this opportunity is for you! Your Day-to-Day ? Location: Pointe-Claire.

Hybrid position, offering an excellent balance between remote work and in-person collaboration. ? Employment Type Permanent Full-Time An Environment Where You Can Grow By joining Medicom, you''ll become part of a passionate Regulatory Affairs and Quality team recognized for its expertise and collaborative approach.





You''ll contribute to the development and ongoing compliance of medical devices distributed across North America and international markets, while expanding your knowledge alongside experienced professionals.

Reporting to the Regulatory Affairs Manager, you will actively participate in a variety of regulatory projects that support the company''s continued growth.

Your Key Responsibilities In this role, you will have the opportunity to: Participate in regulatory activities related to products marketed throughout North America.

Support new product development projects by assisting with the preparation and maintenance of regulatory documentation.

Contribute to product and establishment registrations, as well as license renewals.

Review and maintain product labeling to ensure regulatory compliance.

Participate in post-market surveillance activities, including regulatory assessments, vigilance documentation, and product recall support.

Respond to regulatory inquiries from commercial teams, customers, and international partners.

Assist in preparing documentation required for regulatory audits and inspections.

Contribute to the continuous improvement of regulatory processes.

Ensure compliance with applicable regulatory requirements, including FDA regulations, Health Canada requirements, ISO 13485, the European MDR, and other relevant standards.

Help maintain the quality of technical documentation and regulatory files throughout the product lifecycle.

What We''re Looking For We''d love to hear from you if you have: Bachelor''s degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related field.

One to three years of experience in Regulatory Affairs within the medical device industry or another highly regulated environment.

Experience with regulatory documentation, product registrations, regulatory submissions, or post-market activities.

Good understanding of regulatory requirements such as FDA QSR/QMSR, ISO 13485, Health Canada regulations, EU MDR, or other applicable regulatory frameworks.

Strong organizational skills and exceptional attention to detail.

Ability to manage multiple projects simultaneously while meeting deadlines.

Team-oriented mindset, ability to work independently, and excellent communication skills.

Additional training or certification in Regulatory Affairs is considered an asset.

Availability for occasional travel (less than 5% of the time). 6 Great Reasons to Apply! Permanent full-time position with a hybrid work model.

Opportunity to grow your expertise with a global leader in the medical industry.

Meaningful projects that directly contribute to the health and safety of communities. A collaborative team that encourages professional development and knowledge sharing.

An environment that values innovation, continuous improvement, and operational excellence.

Comprehensive medical and dental benefits Ready for Your Next Challenge? Would you like to put your expertise to work for a company whose mission has a real impact on people''s health? Medicom could be your next career destination! Apply today.

And if this opportunity isn''t quite the right fit for you, don''t hesitate to reach out to the CameleonHR team.

We''re always looking for talented professionals and would be happy to help you find your next career opportunity.

We look forward to meeting you!

📌 Associate Regulatory Affairs Specialist (Pointe-Claire)
🏢 Cameleon RH
📍 Pointe-Claire