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Medisca

Associé en conformité | Compliance Associate

Montreal, QC, Canada

Full-time

Apply About employer

Applications open in a new tab.

Job details

Job type: Full-time
Posting language: English · French
Posted: Oct 14, 2026

Original job description

English section of this bilingual listing.

Medisca is a global company leveraging strong partnerships to serve healthcare professionals across diverse wellness disciplines. Offering extensive and essential solutions - including pharmaceutical ingredients and service, mixing technology manufacturing, analytical testing, and education – Medisca is bridging the gaps in healthcare with an unwavering commitment to precision, innovation, and societal impact.

The Compliance Associate is responsible for ensuring compliance of all regulatory requirements in accordance with local state and federal laws of Medisca facilities and business partners. Key objectives are to ensure compliance within all Medisca facilities and markets by reviewing regulatory requirements for product launches, maintenance of regulatory licences/products as applicable.

The Opportunity

Responsibilities & Duties:

Compliance

Ensure compliance within all Medisca facilities and markets (Canada, USA, Australia and International).
Keep abreast of state, provincial and federal regulations.
Create internal regulatory guides for employee training.
Create and review Standard Operating Procedures (SOPs) to ensure compliance with applicable regulations through change request process.
Attend seminars, webinars and meetings hosted by regulatory bodies.

Product Launches/Business Initiatives

Review of regulatory requirements for product launches/business initiatives.
Conduct regulatory research to support management for Medisca’s operations and business initiatives.
Support regulatory projects by collaborating with other departments.
Review product labeling and marketing material within established timelines through an end-to-end process to ensure regulatory, compliance and business needs are met.
Assess compliance of Research and Development (R&D) formula ingredients and final formulations according to conditions of use.
Provide risk assessments on suitability and safety of product ingredients.
Respond to all internal/external inquiries.

Regulatory Licenses/Product Filings

Update and maintain regulatory licenses and product fillings (as applicable).
Apply and renew licenses across all Medisca facilities.
Conduct product filings (regulatory package submissions) as applicable with regulatory agencies.
Track and maintain regulatory correspondence and submissions.
Liaise with various internal and external groups to collect necessary documents/information for compliance.

Pharmacovigilance Activities

Update assigning identifiers using the Medical Dictionary for Regulatory Activities (MedDRA), for adverse drug reaction cases.
Report and submit adverse drug reactions (ADR) in accordance with Health Canada Regulations.
Follow up with clients until the ADR evaluation is complete.
Monitor signal detection findings.
Prepare annual summary report.
Vendor Qualification Program
Review and/or Approve manufacturers and products per Medisca’s vendor qualification program.
Evaluate and approve suppliers based on performance metrics and regulatory compliance.
Validate manufacturer’s GMP evidence against regulatory requirements.
Provide company-based approvals based on US, Canadian and Australian regulatory requirements.
Approve product specifications per monographed and non-monographed standards.
Confirm manufacturer stability data.
Collaborate with manufacturers on the review and approval of quality agreements.
Apply risk-based approaches for product and manufacturer approvals.
Review and assess supplier change notifications and determine company impact.
Monitor regulatory changes affecting supply and demand of key products and advise relevant stakeholders.
Serve as liaison for supplier quality technical inquiries after initial review of quality documentation obtained by the procurement team.

Qualifications:

Bachelor’s degree in a Science related field
Minimum two (2) to four (4) years of experience in Quality or Regulatory Affairs
Knowledge of FDA and Health Canada regulations
Knowledge in project management
Knowledge of Microsoft Office suite (Word, Outlook and Excel) required
Knowledge of Creatio
Strong writing skills
Reliable, accountable, detail-oriented
Organized, very good judgment and decision making skills

What’s in it for you…

We invest time and resources into making sure Medisca is as good as the people we hire.

Work/Life Balance - 37.50 hour workweek with early Fridays all year long, PTO and vacation policy
Invest in your health – Choice of modular plans, health spending account and free Telemedicine
Flexible work environment – Hybrid work schedule with home office reimbursement program
Your Future is Bright – Opportunities to learn and grow within Medisca
Save for your Future – Medisca contributes to a deferred profit sharing plan (DPSP) when you invest in RRSPs
Help us grow – Employee Referral Program
We like to have fun – company events throughout the year

We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.

We are an equal opportunity employer.

Read the full bilingual original

Medisca est une entreprise mondiale qui s’appuie sur des partenariats solides pour servir les professionnels de la santé dans diverses disciplines liées au bien-être. En proposant des solutions complètes et essentielles, y compris des ingrédients et des services pharmaceutiques, la fabrication de technologies de mélange, des tests analytiques et la formation, Medisca comble les lacunes en matière de soins de santé grâce à un engagement inébranlable en faveur de la précision, de l’innovation et de l’impact sociétal.

L’associé(e) en conformité est chargé d’assurer toutes les exigences réglementaires conformément aux lois nationales et fédérales des installations de Medisca et de ses partenaires commerciaux. Les principaux objectifs sont d’assurer la conformité de toutes les installations et des marchés de Medisca en examinant les exigences réglementaires pour les lancements de produits, le maintien des licences/produits réglementaires, le cas échéant.

L'opportunité

Responsabilités et fonctions :

Conformité

Assurer la conformité dans tous les établissements et marchés de Medisca (Canada, États-Unis, Australie et International).
Se tenir au courant des règlements étatiques, provinciaux et fédéraux.
Créer des guides réglementaires internes pour la formation des employés.
Créer et passer en revue les procédures normales d’exploitation (PNE) pour assurer la conformité aux règlements applicables au moyen du processus de demande de changement.
Assister à des séminaires, des webinaires et des réunions organisées par des organismes de réglementation.

Lancement de produits / initiatives commerciales

Examen des exigences réglementaires pour les lancements de produits/initiatives commerciales.
Mener des recherches réglementaires pour soutenir la gestion des opérations et des initiatives commerciales de Medisca.
Appuyer les projets de réglementation en collaborant avec d’autres ministères.
Examiner l’étiquetage des produits et le matériel de marketing dans les délais établis au moyen d’un processus de bout en bout pour s’assurer que les exigences réglementaires, de conformité et opérationnelles sont satisfaites.
Évaluer la conformité des ingrédients des formules de recherche et développement (R-D) et des formulations finales selon les conditions d’utilisation.
Fournir des évaluations des risques sur l’adéquation et la sécurité des ingrédients du produit.
Répondre à toutes les demandes internes et externes.

Licences réglementaires/dépôts de produits

Mettre à jour et maintenir les licences réglementaires et le remplissage des produits (au besoin).
Appliquer et renouveler les licences dans toutes les installations de Medisca.
Effectuer les dépôts de produits (présentations de documents réglementaires), le cas échéant, auprès des organismes de réglementation.
Suivre et tenir à jour la correspondance et les présentations réglementaires.
Assurer la liaison avec divers groupes internes et externes pour recueillir les documents et les renseignements nécessaires à la conformité.

Activités de pharmacovigilance

Mise à jour de l’attribution des identificateurs à l’aide du Dictionnaire médical des activités de réglementation (MedDRA) pour les cas d’effets indésirables des médicaments.
Déclarer et soumettre les réactions indésirables aux médicaments (EIM) conformément au Règlement de Santé Canada.
Suivi auprès des clients jusqu’à ce que l’évaluation EIM soit terminée.
Surveiller les résultats de la détection des signaux.
Préparer un rapport de synthèse annuel.

Programme de qualification des fournisseurs

Examiner et/ou approuver les fabricants et les produits conformément au programme de qualification des fournisseurs de Medisca.
Évaluer et approuver les fournisseurs sur la base d'indicateurs de performance et de conformité réglementaire.
Valider les preuves de bonnes pratiques manufacturières (GMP) par rapport aux exigences réglementaires.
Fournir des approbations basées sur les exigences réglementaires américaines, canadiennes et australiennes.
Approuver les spécifications des produits selon les normes monographiées et non monographiées
Confirmer les données de stabilité du fabricant.
Collaborer avec les fabricants à l'examen et à l'approbation des accords de qualité.
Appliquer des approches en fonction du risque pour l'approbation des produits et des fabricants.
Examiner et évaluer les notifications de changement de fournisseur et déterminer l'impact sur l'entreprise.
Suivre les changements réglementaires affectant l'offre et la demande de produits clés et conseiller les parties prenantes concernées.
Assurer la liaison avec les fournisseurs pour les questions techniques relatives à la qualité après l'examen initial de la documentation sur la qualité obtenue par l'équipe chargée des achats.

Qualifications:

Baccalauréat dans un domaine scientifique
Au moins deux (2) à quatre (4) ans d’expérience dans le domaine de la qualité ou des affaires réglementaires
Connaissance des règlements de la FDA et de Santé Canada
Connaissances en gestion de projet
Connaissance de la suite Microsoft Office (Word, Outlook, Excel) requise
Connaissance de Creatio
Excellentes compétences en rédaction
Fiabilité, responsabilité, souci du détail
Sens de l’organisation, très bon jugement et capacité de prendre des décisions

Ce que cela vous apporte...

Nous investissons du temps et des ressources pour nous assurer que Medisca est à la hauteur des personnes que nous embauchons.

Équilibre vie professionnelle/vie personnelle - Semaine de travail de 37,50 heures avec des vendredis qui terminent plus tôt toute l'année, politique de congés payés et de vacances.
Investissez dans votre santé - Choix de plans modulaires, compte de dépenses de santé et télémédecine gratuite.
Votre bien-être est important – Programme bien-être offert
Environnement de travail flexible - Horaire de travail hybride avec programme de remboursement du bureau à domicile.
Votre avenir est prometteur - Opportunités d'apprentissage et d'évolution au sein de Medisca.
Épargnez pour votre avenir - Medisca contribue à un régime de participation différée aux bénéfices (RPDB) lorsque vous investissez dans des REER.
Aidez-nous à grandir - Programme de recommandation des employés
Un emplacement centralisé - Parking gratuit/accessible par les transports en commun ; un centre commercial accessible à pied pour le déjeuner ou l'épicerie.
Nous aimons nous amuser - Événements d'entreprise tout au long de l'année

Nous remercions tous les candidats de leur intérêt; toutefois, seuls les candidats sélectionnés pour entrevue seront contactés.

Nous souscrivons au principe de l’équité en matière d’emploi.

Dans ce document, le générique masculin est utilisé sans aucune discrimination, et uniquement dans le but d’alléger le texte.

English

The Opportunity

Responsibilities & Duties:

Compliance

Ensure compliance within all Medisca facilities and markets (Canada, USA, Australia and International).
Keep abreast of state, provincial and federal regulations.
Create internal regulatory guides for employee training.
Create and review Standard Operating Procedures (SOPs) to ensure compliance with applicable regulations through change request process.
Attend seminars, webinars and meetings hosted by regulatory bodies.

Product Launches/Business Initiatives

Review of regulatory requirements for product launches/business initiatives.
Conduct regulatory research to support management for Medisca’s operations and business initiatives.
Support regulatory projects by collaborating with other departments.
Review product labeling and marketing material within established timelines through an end-to-end process to ensure regulatory, compliance and business needs are met.
Assess compliance of Research and Development (R&D) formula ingredients and final formulations according to conditions of use.
Provide risk assessments on suitability and safety of product ingredients.
Respond to all internal/external inquiries.

Regulatory Licenses/Product Filings

Update and maintain regulatory licenses and product fillings (as applicable).
Apply and renew licenses across all Medisca facilities.
Conduct product filings (regulatory package submissions) as applicable with regulatory agencies.
Track and maintain regulatory correspondence and submissions.
Liaise with various internal and external groups to collect necessary documents/information for compliance.

Pharmacovigilance Activities

Update assigning identifiers using the Medical Dictionary for Regulatory Activities (MedDRA), for adverse drug reaction cases.
Report and submit adverse drug reactions (ADR) in accordance with Health Canada Regulations.
Follow up with clients until the ADR evaluation is complete.
Monitor signal detection findings.
Prepare annual summary report.
Vendor Qualification Program
Review and/or Approve manufacturers and products per Medisca’s vendor qualification program.
Evaluate and approve suppliers based on performance metrics and regulatory compliance.
Validate manufacturer’s GMP evidence against regulatory requirements.
Provide company-based approvals based on US, Canadian and Australian regulatory requirements.
Approve product specifications per monographed and non-monographed standards.
Confirm manufacturer stability data.
Collaborate with manufacturers on the review and approval of quality agreements.
Apply risk-based approaches for product and manufacturer approvals.
Review and assess supplier change notifications and determine company impact.
Monitor regulatory changes affecting supply and demand of key products and advise relevant stakeholders.
Serve as liaison for supplier quality technical inquiries after initial review of quality documentation obtained by the procurement team.

Qualifications:

Bachelor’s degree in a Science related field
Minimum two (2) to four (4) years of experience in Quality or Regulatory Affairs
Knowledge of FDA and Health Canada regulations
Knowledge in project management
Knowledge of Microsoft Office suite (Word, Outlook and Excel) required
Knowledge of Creatio
Strong writing skills
Reliable, accountable, detail-oriented
Organized, very good judgment and decision making skills

What’s in it for you…

We invest time and resources into making sure Medisca is as good as the people we hire.

Work/Life Balance - 37.50 hour workweek with early Fridays all year long, PTO and vacation policy
Invest in your health – Choice of modular plans, health spending account and free Telemedicine
Flexible work environment – Hybrid work schedule with home office reimbursement program
Your Future is Bright – Opportunities to learn and grow within Medisca
Save for your Future – Medisca contributes to a deferred profit sharing plan (DPSP) when you invest in RRSPs
Help us grow – Employee Referral Program
We like to have fun – company events throughout the year

We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.

We are an equal opportunity employer.

Apply About employer

More about this job

Responsibilities

The Compliance Associate ensures all Medisca facilities and business partners adhere to national and federal regulatory requirements. Responsibilities include managing product launches, maintaining regulatory licenses, conducting pharmacovigilance, and overseeing the vendor qualification program.

Requirements

Candidates must hold a bachelor's degree in a science-related field and possess two to four years of experience in quality or regulatory affairs. Proficiency in FDA and Health Canada regulations, project management, and Microsoft Office is required.

Skills

Regulatory affairs
Quality assurance
FDA regulations
Health Canada regulations
Project management
Microsoft Office
Creatio
Technical writing
Pharmacovigilance
MedDRA
Risk assessment
Vendor qualification
GMP compliance
Regulatory filings
Standard operating procedures

Benefits

Work/life balance
Paid time off
Vacation policy
Modular health plans
Health spending account
Free telemedicine
Wellness program
Hybrid work schedule
Home office reimbursement
Learning and growth opportunities
Deferred profit sharing plan
RRSP matching
Employee referral program
Free parking

Visa sponsorship

Not detected in the job text

Keywords

Compliance
Regulatory Affairs
Quality Assurance
FDA
Health Canada
Pharmacovigilance
MedDRA
GMP
SOP
Vendor Qualification
Risk Assessment
Product Launch
Creatio
Microsoft Office
Pharmaceuticals
Regulatory Filings
Stability Data
Quality Agreements
Project Management
Labeling
Marketing Material Review

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