Regulatory Affairs and Quality Assurance Manager

1 month ago


Oakville, Canada Xediton Pharmaceuticals Full time

**Vacancy Overview**

The Regulatory Affairs & QA Manager is responsible for obtaining Drug, Medical Devices and Natural Health Product registrations with Health Canada. The incumbent is responsible in ensuring that all current products are in compliance with Health Canada. The Regulatory Affairs and QA Manager will support internal management.

**Company Description**
- Xediton is a privately-held pharmaceutical company with a focus on meeting the needs of patients, physicians, and partners. We are located in Oakville, Ontario.
- Department:

- **Regulatory Affairs & Quality Assurance**
- Project Location(s):

- **Oakville**
- Education:

- **Canadian University Science Degree**
- Salary:

- **$80,000 to $100,000 per annum**
- Job Type:

- **Full Time**

**Skills & Experience**

**Educational Qualification**
Canadian University Science Degree or degree recognized as equivalent by a Canadian University or Accreditation body in Sciences with at least five years of previous Regulatory Affairs and QA experience. An additional RA Diploma is an asset

**Competencies**:

- Thorough understanding of Canadian Regulatory requirements, including interpretation of the Food & Drug Act and Regulations and a working knowledge of ICH requirements.
- Extensive Knowledge of Canadian GMPs
- Applies good document management practices.
- Hands-on working knowledge of eCTD structure and requirements
- Proven track record of compiling eCTD dossiers
- Modules 1 to 5
- Proficient computer skills, which would include Microsoft Office (Word, Excel, Outlook)
- Excellent communication skills(written and oral)
- Strong Project Management skills
- Superior organizational skills, with the ability to prioritize and handle multiple tasks and deadlines, works well under pressure and has a sense of urgency
- Self-starter who is able to work independently with mínimal supervision

**Responsibilities**

Specific responsibilities include:

- Lead in the preparation, compilation, notification, amending and submissions of Drugs in the eCTD format to Health Canada to obtain market authorization
- Preparation and filing of Medical Devices and Natural Health Products to Health Canada
- Ability to Interpret clinical, scientific data and information
- Respond to requests from Health Canada - clarification for new submissions and compliance for existing products.
- Lead all Health Canada interactions
- Ensure all HC requirements and deadlines are met as it relates to annual drug notifications, Site License and DEL renewals.
- Lead regulatory inspections, lead internal and regulatory audits as required and execute the necessary corrective actions
- Maintain Standard Operating Procedures; Review of documentation for GMP purposes
- GMP responsibilities - including but not limited to leading investigations, reviewing and approving deviations and change controls
- Evaluate complaint reports for accuracy and working with the Pharmacovigilance team
- Maintain all documents - Batch Records, Master Manufacturing and Packaging Records
- Work with local and foreign site organizations on GMP matters to resolve issues as needed
- Provide technical and regulatory advice and support to the Business Development Team; Conduct risk assessment of Business Development projects and develop regulatory strategies.
- Ability to interpret and summarize clinical data
- Ensure that product labelling, package inserts and product monograph are accurate and compliant
- Finished Product Release
- Lead in the development of procedures and processes to ensure compliance with the Food and Drug Act and Regulations
- Work with external stakeholders and consultants

**Salary**

$80,000 to $100,000 per annum



  • Oakville, Canada XEDITON PHARMACEUTICALS INC Full time

    **Company Description**: Xediton is a privately-held pharmaceutical company with a focus on meeting the needs of patients, physicians, and partners. We are located in Oakville, Ontario. **REGULATORY AFFAIRS and QUALITY ASSURANCE MANAGER** **Job Description & Key responsibilities** The Regulatory Affairs & QA Manager is responsible for obtaining Drug,...


  • Oakville, Canada AceAge Full time

    AceAge is a healthcare technology company, creating intuitive products to improve health outcomes and empower patients to live healthier and better lives. In close collaboration with healthcare personnel and our users, we have developed Karie - a personal health companion that organizes, schedules and dispenses medication with one-button technology. With...


  • Oakville, Canada Natus Medical Incorporated Full time

    **Regulatory Affairs Specialist** ***Oakville, ON** **As a TEAMMATE**: The **Regulatory Affairs Specialist** specializes in understanding international regulatory requirements to support the proper design and development of medical devices. You could expect to work with product development teams to ensure that our products meet regulatory compliance...


  • Oakville, Canada Natus Medical Incorporated Full time

    **Welcome to Natus Medical Incorporated**: We’re the leading manufacturer of medical devices and software for a range of specialities, including new-born care, neurology, sleep, hearing and balance markets. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment solutions. Our Irish base in Gort,...

  • Quality Assurance

    2 months ago


    Oakville, Canada Procor Full time

    **Quality Assurance (QA) Manager - Oakville, Ontario** Procor Limited manages Canada’s largest private tank car lease fleet and operates an extensive repair network across the country. Our fleet has grown to include more than 30,500 special purpose tank and freight cars. Procor also operates 27 repair locations servicing the petroleum, petrochemicals,...


  • Oakville, Canada Robust Gear & Industries Full time

    **ROLE**:Quality System & Assurance Manager **DIRECT REPORT**: Operations Manager **JOB DESCRIPTION** **OBJECTIVES** - Achieve and Maintain Dimensional Conformance for manufactured components. - Ensure documentation is produced and complete, with a focus on sharing information. - Actively pursue improvement in process and machining. - Meets company...


  • Oakville, Canada Moltec International Full time

    **JOB RESPONSIBILITIES** **Job Title**: Quality Assurance Specialist **Reports to**: Thomas Moller **Job Objective**: - Ensure that the core quality aspects of the current ISO system are running smoothly and effectively. Overall responsibility for ensuring that the Inventory Management, RMA, and Corrective Action systems are efficient and effective....


  • Oakville, Canada Taima Extracts Inc. Full time

    **Position Title** **QA/QC Technician** Job Responsibility **Description** Quality Assurance Technician shall ensure that the Quality Management System of the licensed manufacturing site is implemented and monitored as per procedure. Furthermore, the position requires to be vigilant in regulations and efficient at implementing regulatory requirements in...

  • Food Safety

    7 days ago


    Oakville, Canada Btrust Supermarket Full time

    **The role**: The position is responsible for the regional food safety and quality assurance program, ensuring that employee’s practices and products meet all relevant regulatory requirements and that they support the attainment of primary business objectives. **Major Responsibilities**: - Conduct product evaluation and improvement projects - Participate...

  • Food Safety

    1 month ago


    Oakville, Canada Btrust Supermarket Full time

    **The role**: The position is responsible for the regional food safety and quality assurance program, ensuring that employee’s practices and products meet all relevant regulatory requirements and that they support the attainment of primary business objectives. **Major Responsibilities**: - Conduct product evaluation and improvement projects - Participate...

  • Food Safety

    1 week ago


    Oakville, Canada Btrust Supermarket Full time

    **The role**: The position is responsible for the regional food safety and quality assurance program, ensuring that employee’s practices and products meet all relevant regulatory requirements and that they support the attainment of primary business objectives. **Major Responsibilities**: - Conduct product evaluation and improvement projects - Participate...


  • Oakville, ON, Canada The Bama Companies, Inc. Full time

    The Bama Companies, Inc. Quality Assurance Manager Tulsa , Oklahoma Apply Now Until Filled (CST) | 2435 N Lewis Ave, Tulsa, OK, USA | Salary | QA | Full Time Exciting Opportunity Alert! Do you thrive on ensuring top-notch quality in food manufacturing? As a Full-Time Quality Assurance Manager at The Bama Companies in Tulsa, OK, you'll be at the...


  • Oakville, Canada The MEARIE Group Full time

    **Quality, Revenue Assurance and Compliance Analyst** Oakville Hydro delivers reliable and safe electricity to more than 76,000 individuals, families, and businesses in the Town of Oakville. The company maintains an active commitment to conservation, safety, and is strongly invested in the social and economic well-being of the Oakville community. Oakville...


  • Oakville, Canada The MEARIE Group Full time

    Oakville Hydro delivers reliable and safe electricity to more than 76,000 individuals, families, and businesses in the Town of Oakville. The company maintains an active commitment to conservation, safety, and is strongly invested in the social and economic well-being of the Oakville community. Oakville Hydro is a two-time recipient of the Local Distribution...


  • Oakville, Canada Eurofins Canada BioPharma Full time

    Company Description **_ Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the...


  • Oakville, Canada FCT Full time

    Sommaire de la compagnie Venez travailler pour une entreprise qui est engagée dans la réussite de chacun de ses employés. C’est un milieu de travail où les innovateurs et les collaborateurs se rencontrent et tirent parti des talents de chacun. Un endroit où la diversité est accueillie et célébrée. FCT offre la meilleure assurance titres de...


  • Oakville, Canada Waterloo Brewing Full time

    **Legal & Government Affairs Manager** **Hybrid-** Oakville or Kitchener office Carlsberg Canada Inc. **Company Background** Carlsberg Canada Inc. (CCI) is the Canadian Division of Carlsberg Breweries A/S which is the World’s 3rd largest brewer and one of the fastest growing brewers in the World. With over 100 beer brands in our portfolio Carlsberg...


  • Oakville, Canada VAC Developments Ltd Full time

    Our company is looking to hire a Quality Assurance Supervisor who will be responsiblessuring that all products are defect free and compliant with technical specifications in a professional manner. We're looking for someone with an eye for detail and an interest in continuing education, and we hope to find someone who will work closely with our production...


  • Oakville, Canada VAC Developments Ltd Full time

    Our company is looking to hire a Quality Assurance Supervisor who will be responsible for assuring that all products are defect free and compliant with technical specifications in a professional manner. We're looking for someone with an eye for detail and an interest in continuing education, and we hope to find someone who will work closely with our...


  • Oakville, Canada The Fedcap Group Full time

    **Position Summary**: The Quality Assurance Specialist is responsible for ensuring Fedcap Canada’s established program and organization quality standards are achieved. Working within a wider team, this position provides a critical business function that monitors all elements of our delivery, challenges status quo and supports continuous improvement...