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Medical Device Regulatory Affairs jobs in Mississauga, ON

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    • Completing critical assessments of data and documents to identify gaps compared to regulatory requirements.
    • The role specifically prioritizes, plans, organizes…
    • May work with regulatory affairs personnel to provide PK/PD data in support of regulatory communications and presentations as needed.
    • Lead the planning, coordination, and execution of medical device integration activities within a large healthcare implementation project.
    • Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
    • View all Cardinal Health jobs - Mississauga jobs - Quality Assurance Analyst jobs in Mississauga, ON
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    • 0–3 years of experience in the medical device industry or quality.
    • Prior experience as a complaint specialist in the medical device industry is a plus.
    • Industry Advisor will serve as a strategic advisor and subject matter expert for key industries and markets.
    • In this role, you will provide industry expertise,…
    • Minimum of two years’ experience in the MedTech and/or medical device industry in sales or related roles required.
    • College or University degree required.
    • Minimum of 5 years of related experience in a medical device or healthcare environment, including clinical and technical involvement, with hands-on experience…
    • Mississauga, Canada | Full time | Home-based | R1562743.
    • R1558503 Directeur associé, Relations clientèle, gestionnaire de projet – Appareils connectés / Client…
    • Familiarity with pharmaceutical, medical device, biotech, or broader healthcare commercialization challenges.
    • This role helps turn complex client questions into…
    • Prior experience planning, executing, and reporting studies across the medical device development lifecycle, including late-stage R&D, V&V, and/or preclinical…
    • Minimum 7 years of Quality Engineering or Quality Systems experience within a regulated medical device environment.
    • Plan, conduct, and support internal audits.
    • Responsible to work with RA partners on regulatory submission prioritization and tracking.
    • Manager is responsible for the overall downstream strategic product…
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    • Support medical device safety testing and ongoing product compliance activities.
    • Experience working in medical device or another regulated manufacturing…
    • You will also interact closely with regulatory affairs teams and contribute to regulatory filings and strategy.
    • CTA, CDM or RAM background.
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Career Resources:

Lead Consultant (Hybrid)
Q&C Services
2000 Argentia Road, Mississauga, ON L5N 1V8
$70,000–$85,000 a year
Permanent, Full-time
Apply now

Job details

$70,000–$85,000 a year
Paid time off, Vision care, Dental care, Life insurance, Employee assistance program, RRSP match, Extended health care, Flexible schedule
Permanent, Full-time
2000 Argentia Road, Mississauga, ON L5N 1V8

Full job description

Job Summary
This pharmaceutical consultant role focuses on applying your GMP knowledge and experience to various projects, such that the client is confident in the approach and timing of execution of the project. Our consultants work independently within a team environment to ensure activities are undertaken in a timely manner. This position may require onsite consultant engagements with in the pharmaceutical industry.

We are looking for consultants who want to apply their in-depth quality and compliance knowledge and out-of-the-box thinking to challenging projects with our clients. Our projects cover, but are not limited to: deviation investigations, change controls, CAPA, auditing, management of quality systems, delivering of training, batch document review, product releases, related to the importation of pharmaceuticals, biologics, NHPs and Medical Devices.

In this broad-based role, you will support the projects assigned to you, meeting the client’s needs. The role specifically prioritizes, plans, organizes and executes projects related to quality and compliance of health products to ensure smooth implementations. The role may involve coordinating/working with client personnel to meet project goals.

Responsibilities

Reporting to the Manager Quality Services or Manager of Compliance Services, the Lead/Senior Consultant is responsible for:

  • Establishing project plans that capture all aspects of the scope of work
  • Prioritizing and managing compliance projects
  • Completing critical assessments of data and documents to identify gaps compared to regulatory requirements
  • Communicating project milestones on a monthly basis
  • Completing client assigned tasks: deviation investigations, management of quality systems, review of documentation
  • Developing documentation as required by the project: SOPs, protocols, reports, etc.
  • Conducting audits both internal and external
  • Releasing product to market
  • Hosting Health Canada audits

Requirements

If you are a Quality Assurance professional in the Pharmaceutical industry with at least 4-7 years experience, we have the environment and exposure to the type of work you want to do.

  • Education - Bachelors' degree in Science or related field required

Experience in the following is an asset:

  • Importation
  • Change Controls
  • Deviation investigations
  • Master manufacturing/batch record review and lot release
  • Health Canada audit responses Annual Product Quality Reviews
  • Stability review and assessment

Benefits

Learn about what makes our company unique at www.qualityandcompliance.com

Q&C welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process

Job Types: Full-time, Permanent

Pay: $70,000.00-$85,000.00 per year

Benefits:

  • Dental care
  • Employee assistance program
  • Extended health care
  • Flexible schedule
  • Life insurance
  • On-site parking
  • Paid time off
  • RRSP match
  • Vision care

Application question(s):

  • Have you attached your updated resume containing your full contact details including a valid email address? Without this we will not be able to contact you.
  • Are you good with commuting for work?

Education:

  • Bachelor's Degree (required)

Work Location: Hybrid remote in Mississauga, ON L5N 1V8

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