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

Regulatory Affairs Medical Devices jobs

Sort by: -
    • Proven experience in regulatory affairs or a related field, with a strong understanding of compliance requirements.
    • Medical Devices (Class I–II).
    • Maintain regulatory licenses and all foreign sites in a valid state.
    • Bring creativity and passion to the organization and its services and possess a broad…
    • Provides, as subject matter expert, strategic and operational regulatory input (including Health Authority Insights) on projects including, but not limited to,…
    • Exposure to regional or global medical roles in a matrix organization.
    • Strong experience engaging with HCPs/Medical Experts and leading field medical teams.
    • Interacts with internal and external groups to provide regulatory affairs consultative support for projects.
    • Initiates and manages regulatory affairs projects…
    • Support internal and external regulatory and quality audits.
    • Ensure product registrations remain current and compliant with applicable regulatory requirements.
    • Proficient knowledge of new product and process development, current regulatory issues and regulations in Canada and the U.S. for NHPs/dietary supplements,…
    • Puzzle Medical Devices® Inc. développe une pompe cardiaque minimalement invasive destinée aux patients atteints d’insuffisance cardiaque avancée.
    • Strong background in B2B sales, ideally within healthcare, medical devices, medical supplies, or related distribution environments.
    • Support internal and regulatory audits.
    • API offers a generous paid time off (PTO) policy that includes vacation days, medical/personal days, and holidays.
    • Completing critical assessments of data and documents to identify gaps compared to regulatory requirements.
    • The role specifically prioritizes, plans, organizes…
  • View similar jobs with this employer
    • Looking to be part of a transformational digital engineering and manufacturing practice?
    • How about an opportunity to help world-class clients solve their…
    • The role focuses on the preparation, compilation, and publishing of regulatory submissions in multiple electronic formats, ensuring compliance with regional…
    • Perform audits for clients’ medical device quality systems and technical information to the requirements of ISO 13485 and other regulatory requirements such as…
    • Prepare written responses to deficiency letters from regulatory agencies in the stated time frame.
    • Good problem-solving abilities are required to prepare…
Get e-mail updates for the latest Regulatory Affairs Medical Devices 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