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

Quality Regulatory Medical Device jobs

Sort by: -
    • Perform surveillance activities for ongoing product quality and safety.
    • Proven experience in regulatory affairs or a related field, with a strong understanding…
    • Assemble small, high-precision medical devices following detailed work instructions.
    • This role involves the precise assembly and soldering of small electronic…
    • Minimum 5 years in quality and regulatory affairs management within the medical device sector.
    • Ensure appropriate training on quality and regulatory topics…
    • A minimum of five years of quality assurance experience is required.
    • Assist process owners in the interpretation of quality, technical performance and business…
  • View similar jobs with this employer
    • Compile and analyze quality performance data, develop graphs, charts and quality reports.
    • Experience supporting APQP, PFMEA, and launch‑related quality…
    • Participate in and lead initiatives that promote a strong quality culture.
    • Engage suppliers in defining and deploying required actions to eliminate quality…
  • View similar jobs with this employer
    • Communicate and maintain the UPS Healthcare quality plan to sustain the Company’s program in compliance with quality system requirements.
    • Review and approve quality agreements.
    • Support EU regulatory activities, including RFI responses, regulatory requirement review, and IMPD updates.
    • Experience supporting audits and regulatory submissions, with the ability to defend design and quality documentation.
    • At ATS Healthcare we partner with the top manufacturers, producers and distributors of pharmaceutical products, medical devices, medical surgical products and…
    • 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.
    • Support internal and regulatory audits.
    • This role is responsible for creating and managing GMP-compliant technical documentation, ensuring regulatory adherence,…
    • The QA Inspector is responsible for inspecting incoming materials, inspecting and testing Final medical devices.
    • Knowledge of quality and conformity systems.
    • Ensure the quality-related issues are resolved promptly and the rework is verified to ensure it meets the quality and drawing requirements.
    • The position of QMS/Document Coordinator includes, but is not limited to, coordinating QA related issues, maintaining and updating records, providing…
Get e-mail updates for the latest Quality Regulatory Medical Device 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