Skip to main content
Post your resume and find your next job on Indeed!

Medical Device Quality System jobs

Sort by: -
    • Perform surveillance activities for ongoing product quality and safety.
    • This role will also provide quality assurance support through maintenance of the RA SOPs…
    • Strong debugging skills, especially with Ethernet-connected devices.
    • Familiarity with embedded systems, firmware, and hardware debugging tools.
    • Our Cambridge facility specializes in the design and manufacturing of neutron flux monitoring devices and in-core instrumentation systems used in nuclear power…
    • Knowledge of quality and conformity systems.
    • The QA Inspector is responsible for inspecting incoming materials, inspecting and testing Final medical devices.
    • Maintain documents within QMS systems.
    • We encourage our employees to prioritize their well-being and enjoy quality time away from work.
    • Accurately record all manufacturing documentation and document quality records.
    • Highly detail oriented, quality focused and meticulous individual.
    • NeuroRx est un chef de file dans l'analyse avancée d'images cérébrales et la gestion de projets au service de l'industrie pharmaceutique et biotechnologique.
    • Familiarity with IFS quality module or similar ERP systems, SharePoint, and Copilot.
    • Define inspection standards and support resolution of quality issues.
    • Nous avons un poste du lundi au vendredi, de jour, à 40 heures par semaine.
    • Évaluer la qualité des produits finis et des matières premières conformément aux…
    • Model data flows and makes architectural decisions based on product requirements, schedule, device limitations, bandwidth, latency, and system-level constraints…
    • Participate in the design and development of medical devices while following a quality system in accordance with ISO 13485.
    • Job Types: Full-time, Permanent.
    • Assembly of components to build functioning devices.
    • Responsible for the fabrication and assembly of ultrasound transducers for various medical applications.
    • Orders medical supplies as required.
    • Functions in a supportive role for other medical specialties in operating mechanical devices to assist in the conservation…
    • L’Agent(e) Qualité est un point central des communications entre Mindcore, ses clients et ses fournisseurs.
    • Gestion des communications qualité avec les clients…
    • Knowledge of data integrity principles, master document control, Change controls and CAPA systems.
    • Familiarity with ERP/QMS systems, Audit trail awareness,…
Get e-mail updates for the latest Medical Device Quality System jobs

By creating a job alert, you agree to our Terms . You can change your consent settings at any time by unsubscribing or as detailed in our terms.

Career Resources:

Job Post Details

Pharmaceutical Regulatory Affairs Specialist - job post

CRL Synergy
Calgary, AB T2S 1W3
$68,000–$100,000 a year - Full-time

Job details

Pay

  • $68,000–$100,000 a year

Job type

  • Full-time

Location

Calgary, AB T2S 1W3

Benefits

Pulled from the full job description

  • Paid time off
  • Vision care
  • Dental care
  • Life insurance
  • Disability insurance
  • On-site gym
  • Extended health care

Full job description

Job Overview
CRL Synergy, one of Canada’s largest and fastest-growing suppliers of control label products, is seeking a detail-oriented and proactive Regulatory Affairs (RAS) Specialist.CRL Synergy is seeking a Regulatory Affairs (RAS) Specialist who can thrive in a fast-paced environment that involves working in an office team environment.

The Regulatory Affairs Specialist is the site lead for all Health Canada submissions and post-market activities covering four product categories sold across Canada:

  • Drugs (DIN-assigned OTC)
  • Cosmetics
  • Medical Devices (Class I–II)
  • Natural Health Products (NHPs/NPNs)

The RAS plans, authors, files and maintains regulatory submissions and dossiers, and ensures compliant labelling/advertising.

This role will also provide quality assurance support through maintenance of the RA SOPs, ensuring they are current and implemented, perform data collection, and subsequent analysis.

The successful candidate will provide support for new product development, ensuring Health Canada and customer requirements are being met, including labelling accuracy for new and modified product.

Responsibilities

  • Oversight of Pharmacovigilance program

· Collaborate with cross-functional teams to implement corrective and preventive actions (CAPA) related to customer complaints.

· Participate in risk management activities and contribute to the development of risk assessment strategies.

  • Ensuring accurate record keeping and filing as per organizational procedures.
  • Handle clerical and administrative activities.
  • Review and assess customer complaints for adverse reactions and reportable incidents. Perform surveillance activities for ongoing product quality and safety.
  • Complete Annual Summary Reports and perform screening of scientific literature for product safety information.
  • Assisting in updating methods and procedures (SOPs) related to the Quality Management System with a focus on the customer complaint and pharmacovigilance program.

Qualifications

  • Bachelor’s degree in a relevant field; advanced degree preferred.
  • Proven experience in regulatory affairs or a related field, with a strong understanding of compliance requirements.
  • Demonstrated skills in project management, including the ability to manage multiple projects simultaneously.
  • Strong leadership abilities with experience in supervising teams or mentoring staff.
  • Excellent analytical skills with a focus on process improvement methodologies.
  • Familiarity with sales or business development processes is a plus.
  • Exceptional communication skills, both written and verbal, with the ability to effectively convey complex information to diverse audiences. Join us in making a difference through compliance excellence!

Job Type: Full-time

Pay: $68,000.00-$100,000.00 per year

Benefits:

  • Company events
  • Dental care
  • Disability insurance
  • Extended health care
  • Life insurance
  • On-site gym
  • On-site parking
  • Paid time off
  • Vision care

Education:

  • Bachelor's Degree (preferred)

Experience:

  • Regulatory Affairs: 2 years (preferred)

Work Location: In person

Let Employers Find YouUpload Your Resume