Regulatory Affairs Specialist

2 days ago

Montréal, Canada vitaltracer Full time

Work Term: Permanent
- Work Language: English
- Hours: 42 to 44 hours per week
- Education: Master's degree
- Experience: 5 years or more
**Tasks**:

- Analyze and provide advice on the managerial methods and organization of an establishment
- Conduct quality audits
- Develop quality management and quality assurance standards
- Conduct research to determine efficiency and effectiveness of managerial policies and programs
- Propose improvements to methods, systems and procedures
- Coaching
- Plan and control budget and expenditures
- Set up medical laboratory equipment
**Supervision**:

- 1 to 2 people
**Regulatory investigation**:

- Regulatory affairs
**Computer and technology knowledge**:

- Microsoft Visio
- MS Word
- MS Excel
- MS PowerPoint
- MS Outlook
- MS Office
**Industrial processes and biological studies**:

- Product development
**Type of inspection and investigation**:

- Medical devices
**Area of work experience**:

- Medical instruments and devices
- Research and development
**Medical specialization**:

- Biomedical engineering
**Area of specialization**:

- Process improvement
- Risk management
- Organizational analysis
- Operations management
- Operational methods research
- Program evaluation and review
- Ethical oversight and accountability framework assessment
- Project management
- Internal audit
- Cybersecurity
- Facility management
- User experience design
**Work conditions and physical capabilities**:

- Work under pressure
- Tight deadlines
- Overtime required
**Personal suitability**:

- Efficient interpersonal skills
- Excellent oral communication
- Excellent written communication
- Flexibility
- Team player
- Time management
**Screening questions**:

- Are you currently legally able to work in Canada?
- Are you willing to relocate for this position?
- Do you currently reside in proximity to the advertised location?
- Do you have previous experience in this field of employment?
- Do you have the above-indicated required certifications?
- Do you have the necessary equipment for remote work (i.e. internet, home office, etc.)?
- What is the highest level of study you have completed?
- What is your current field of study?
- What is your current level of study?

  • Regulatory Affairs Specialist

    4 days ago

    Montréal, Canada Novartis Full time

    **Summary**: Location: Montreal, #LI-Hybrid About the role: The role reports to Regulatory Affairs Franchise Lead and will work with different team members. Temporary - 9 to 12 months **About the Role**: **Key Responsibilities**: - Assists in the preparation of and/or review of various regulatory submissions for new or marketed products and ensures optimal...

  • Spécialiste, Affaires Réglementaires

    2 weeks ago

    Montréal, Canada Jubilant DraxImage Inc. Full time

    ENGLISH version below_ **Spécialiste, Affaires réglementaires** Rejoignez notre équipe dynamique chez Jubilant Radiopharma en tant que Spécialiste, Affaires réglementaires! Nous recherchons une personne motivée qui s'épanouit dans un environnement en constante évolution et qui est passionnée par la garantie des normes de qualité et de conformité...

  • Spécialiste des affaires réglementaires

    3 hours ago

    montréal, Canada Galerie au Chocolat Inc. Full time

    Galerie au Chocolat and Brockmann Chocolates are premium chocolate manufacturers with operations in Montreal and Delta. We pride ourselves on producing high-quality products that meet rigorous standards of food safety, compliance, and innovation.We are seeking a detail-oriented Regulatory Affairs Specialist to oversee packaging compliance and ensure our...

  • Regulatory Affairs Associate

    4 days ago

    Montréal, Canada Allphase Clinical Research Inc. Full time

    Calian CRO is looking for a Regulatory Affairs Associate on behalf of our client for a limited 12-month term contract with a possibility of renewal. The role will be primarily remote, with occasional attendance in the Montreal office for meetings. Do you have a passion for day-to-day regulatory activities? If so, we would love to hear from...

  • Associate, Regulatory Affairs

    2 weeks ago

    Montréal, Canada Endo International Full time

    Job Description Summary Temporary position for a period of 14 months At Paladin Pharma, we strive to offer a work environment that meets the diverse needs of our team members and advances the goals of the individual, the team and the company, while promoting flexibility, accountability and collaboration. If you're looking for a hybrid work environment,...

  • Regulatory Affairs Associate

    1 week ago

    Montréal, Canada Medisca Pharmaceutique Inc Full time

    **Medisca **is a global corporation with locations throughout North America, Australia, and Europe, that contributes to healthcare by leveraging strong partnerships that deliver customized solutions with an unwavering commitment to quality and innovation. Backed by 30+ years and a strong foundation in pharmaceutical compounding, **Medisca** is a...

  • Regulatory Affairs Compliance Associate

    7 days ago

    Montréal, Canada Novartis Full time

    395204BR **Regulatory Affairs Compliance Associate**: Canada **About the role** Location: Montreal, #LI-Hybrid 13 month contract About the role: We are looking for an organized, collaborative and passionate regulatory affairs professional who is driven to help us deliver our innovative treatments to patients. As a compliance lead, you will report directly...

  • Regulatory Affairs Assistant

    1 week ago

    Montréal, Canada Innovaderm Research Full time

    The Regulatory Affairs Assistant is responsible for handling regulatory documents and maintaining the Investigator’s Study Files (ISFs) for all studies at the clinical research unit. **RESPONSABILITIES** More specifically, the Regulatory Affairs Assistant must: - Track the signatures of regulatory forms (i.e., QIU, FDA1572, financial disclosure forms) and...

  • Chef(fe) aux affaires réglementaires

    2 days ago

    Montréal, Canada Knight Therapeutics Full time

    Ce poste offre une formule de travail hybride, permettant d'effectuer 50 % de ses tâches en télétravail. Cette approche favorise un équilibre entre performance et flexibilité, tout en maintenant une collaboration étroite avec les équipes. Le poste est basé dans notre bureau de Ville Saint-Laurent, à Montréal.À propos du posteNous sommes à la...

  • Chef(fe) aux affaires réglementaires

    2 days ago

    montréal, Canada Knight Therapeutics Full time

    Ce poste offre une formule de travail hybride, permettant d’effectuer 50 % de ses tâches en télétravail. Cette approche favorise un équilibre entre performance et flexibilité, tout en maintenant une collaboration étroite avec les équipes. Le poste est basé dans notre bureau de Ville Saint-Laurent, à Montréal.À propos du posteNous sommes à la...