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Publié il y a 36 mois

Specialist/Project Manager, regulatory affairs

@ FOP Consultants

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Québec

Temps pleinTemporaire1+ ans d’expérience
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FOP Consultants is hiring regulatory affairs consultants for its medical devices clients on temporary or full-time contracts. The role manages medical device regulatory projects, writes submission documents for authorities, and trains staff on regulatory requirements. Remote work is offered according to client needs.

Responsabilités :

  • Gérer les projets liés à la réglementation des dispositifs médicaux
  • Rédiger et réviser les documents pour les autorités réglementaires
  • Rédiger les procédures opérationnelles normalisées (POS)
  • Former le personnel sur les processus réglementaires
  • Assurer la veille réglementaire

Résumé des exigences :

  • Baccalauréat ou maîtrise en sciences ou génie biomédical
  • 1 à 10 ans d'expérience en dispositifs médicaux ou pharmaceutique
  • Connaissance de ISO 13485 et des classes I, IIa, IIb et III
  • Connaissance des règlements de Santé Canada et de la FDA
  • Bilinguisme français et anglais à l'écrit et à l'oral

Outils et compétences

Regulatory affairsStaff trainingMedical device regulationsPharmacologyBiomedical engineeringPharmaceutical industryProject managementCommunication skillsBilingualismClass 5 licenceLeadershipManage several projects

Avantages mentionnés

Congés payés
Source et dates

Type de source non vérifié · jsonld

Date publiée par l’employeur
2023-11-16
Première détection par notre source
2026-10-26
Mise à jour du dossier source
2026-11-09

Ces dates décrivent le dossier source, pas une vérification en direct du recrutement. Consultez l’offre originale.

Détails du poste

NiveauIntermédiaire
DomaineOpérations
Expérience1 an(s) et plus
Heures par semaine40 (estimé)
Milieu de travailBureau, Domicile
PositionSurtout assis
Exigences physiquesphysique faible · ordinateur élevé
LanguesEnglish, French
Permis de conduireun atout
FormationBaccalauréat (exigé), Maîtrise (préféré)
Domaines d’étudesMedical Technology, Chemistry, Biochemistry, Pharmacology, Biomedical Engineering
Avantages mentionnésCongés payés généreux, Aide au transport en commun

Résumé et détails rédigés par l’IA à partir de l’offre; l’offre de l’employeur fait foi.

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Description

Brief description of the position :

In order to meet the needs of our customers in the Medical Devices sector, we are looking for regulatory affairs consultants to carry out various mandates. The main missions would be to support all of the different departments in their regulatory requirements process, participate in staff training regarding regulatory instructions, write documents for the regulations authorities and collaborate on any project involved in medical device regulation.

Main responsibilities :

Without limitation, the main tasks involve:

  • Manage project related to the medical device regulations;
  • Review and write documents for the submission of the regulation’s authorities;
  • Ensure regulatory section is taken into account in every aspect of a project;
  • Proceed to regulatory surveillance to be aware of any changing in order to reduce non conformity risks;
  • Write the standard operating procedures (SOPs) related to regulations;
  • Train or participate to the training of the personnel in charge of regulatory process;
  • Support by your technical expertise the less experienced personnel;
  • Participate to the weekly or monthly meetings about the regulatory cases;
  • Provide solutions to problems encountered and perform all tasks relevant to the mandate;

Qualifications :

  • Bachelor’s or Master’s degree in sciences (Medical Technology, Chemistry, Biochemistry, Pharmacology, etc), in biomedical engineering or any other related discipline;
  • 1 (one) to 10 (ten) years of experience in medical device or pharmaceutical industries;
  • Strong project management skills (an asset);
  • Experience in regulatory affairs in medical device or pharmaceutical industries (an asset);
  • Proven knowledge of ISO 13485 Regulation;
  • Proven knowledge of the medical device classes: I, IIa, IIb et III;
  • Proven knowledge of Health Canada and FDA Regulations;
  • Writing/oral communication skills, English and French;
  • Perfect bilingualism (an asset);
  • Valid class 5 driver’s license (an asset);
  • Mobility, willing to travel (an asset).

Personal skills :

  • Leadership;
  • Rigor et discipline;
  • (Organize), able to manage several projects;
  • Analytical and critical mindset;
  • Perseverance;
  • Humility.

What we offer :

In order to allow the full development of our team members, FOP CONSULTANTS guarantee the support and comfort necessary for the achievement of their mandate. The main advantages offered are as follows:

  • Competitive wages;
  • Group insurance;
  • Professional insurance;
  • Remote work, according to the customer needs;
  • Vacations: 3 weeks;
  • Paid sick leave: 3 days;
  • Monthly transportation fees;
  • Career advancement opportunity;
  • Continuing education.

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