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

Medical Regulatory Affairs jobs

Sort by: -
    • Proven experience in regulatory affairs or a related field, with a strong understanding of compliance requirements.
    • Medical Devices (Class I–II).
    • Conduct audits and inspections of pharmacovigilance processes to ensure compliance with regulatory standards and internal policies.
  • View similar jobs with this employer
    • Minimum 5 years in quality and regulatory affairs management within the medical device sector.
    • Comprehensive medical, dental, and vision coverage.
    • 3+ years of experience in regulatory affairs, compliance, or a related field.
    • Knowledge of international regulatory requirements.
    • Strong knowledge of regulatory and professional standards for physicians in New Brunswick.
    • Medical degree (MD or equivalent) from a recognized medical school.
    • Generate SOPs for regulatory procedures.
    • Ensure all raw material and packaging documents are current and meet regulatory requirements.
    • Strong background in regulatory strategy and Health Canada submissions.
    • Understanding of Health Canada guidances and evolving regulatory initiatives.
    • The role serves primarily as the organization’s Medical Advisor providing strategic medical expertise to leadership on policy, regulatory decisions, complex…
    • Oversee organizational compliance with accreditation standards, legislation, and regulatory requirements.
    • This role is accountable for advancing a culture of…
    • Experience with regulatory and legal research preferred.
    • Excellent verbal and written communication skills required; ability to translate complex regulatory…
    • Support internal and regulatory audits.
    • API offers a generous paid time off (PTO) policy that includes vacation days, medical/personal days, and holidays.
    • Ensure adherence to all regulatory requirements and manage associated organizational risks.
    • Health PEI encompasses acute care facilities, long-term care…
    • Support internal quality audits and external inspections, ensuring compliance with regulatory standards and inspection readiness.
    • Experience with medical writing of clinical and regulatory documents including briefing packages, regulatory summaries, Integrated Summaries of Safety and…
    • Department: Centre for Clinical Ethics.
    • Site: Baycrest and Unity Health Toronto.
    • Hours of Work: in-person Monday to Friday, 37.5 hours per week, some on-call…
Get e-mail updates for the latest Medical Regulatory Affairs 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