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Medical Device Regulatory jobs

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    • Proven experience in regulatory affairs or a related field, with a strong understanding of compliance requirements.
    • Medical Devices (Class I–II).
    • Regulatory Affairs experience with cosmetics, natural health products, OTC drugs or medical devices an asset.
    • In addition, the role will include performing post…
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    • Minimum 5 years in quality and regulatory affairs management within the medical device sector.
    • Comprehensive medical, dental, and vision coverage.
    • Accurately complete study documentation, regulatory records, and periodic reports.
    • Prepare for monitoring visits, audits, and maintain regulatory files.
    • Knowledge of international regulatory requirements.
    • Manage certifications and liaise with regulatory agencies as needed.
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    • General knowledge of SaaS companies, and medical devices.
    • At least 2 years of MedTech or medical devices sales or life-science industry experience.
    • Strong background in regulatory strategy and Health Canada submissions.
    • Understanding of Health Canada guidances and evolving regulatory initiatives.
    • 10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred).
    • 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.
    • API offers a generous paid time off (PTO) policy that includes vacation days, medical/personal days, and holidays.
    • Audit employee training requirements for site and regulatory requirements.
    • Working knowledge of office 365 and able to utilize various technology-based devices.
    • Puzzle Medical Devices® Inc. développe une pompe cardiaque minimalement invasive destinée aux patients atteints d’insuffisance cardiaque avancée.
    • Completing critical assessments of data and documents to identify gaps compared to regulatory requirements.
    • The role specifically prioritizes, plans, organizes…
    • Experience supporting customer audits and regulatory inspections.
    • Comprehensive benefits coverage (medical, dental, vision, EAP & on-demand virtual health care)…
    • Journée d’absence illimitée et payée;
    • Diriger et soutenir les audits internes et externes ainsi que les inspections FDA, Santé Canada et clients.
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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

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