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Regulatory Affairs Manager Medical Device 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).
    • Interacts with internal and external groups to provide regulatory affairs consultative support for projects.
    • Initiates and manages regulatory affairs projects…
    • Manage integration activities involving connected clinical devices such as patient monitors, fetal monitors, dialysis, anesthesia-related devices, and other…
    • The Senior Medical Writer is a key contributor within the medical writing team, responsible for developing clear, accurate, and engaging scientific content…
    • Compile, publish, and validate regulatory submissions in line with health authority requirements.
    • The Publishing Officer will support regulatory submission…
    • Perform audits for clients’ medical device quality systems and technical information to the requirements of ISO 13485 and other regulatory requirements such as…
    • In collaboration with the team and aligned to regulatory and legislative requirements, the Manager will work collaboratively with the leadership team in…
  • View similar jobs with this employer
    • Deliver medical education in person (or virtually if needed), such as lunch and learns / CHE events and conferences to HCPs.
    • Library of online training courses.
    • Support internal and regulatory audits.
    • API offers a generous paid time off (PTO) policy that includes vacation days, medical/personal days, and holidays.
  • View similar jobs with this employer
    • Deliver medical education in person (or virtually if needed), such as lunch and learns / CHE events and conferences to HCPs.
    • Library of online training courses.
    • Contribute to regulatory dossier writing with a high standard of accuracy and clarity.
    • 3–5+ years of regulatory experience in dietary supplements and/or foods;…
  • View similar jobs with this employer
    • Deliver medical education in person (or virtually if needed), such as lunch and learns / CHE events and conferences to HCPs.
    • Library of online training courses.
  • View similar jobs with this employer
    • Deliver medical education in person (or virtually if needed), such as lunch and learns / CHE events and conferences to HCPs.
    • Library of online training courses.
  • View similar jobs with this employer
    • Deliver medical education in person (or virtually if needed), such as lunch and learns / CHE events and conferences to HCPs.
    • Library of online training courses.
    • API offers a generous paid time off (PTO) policy that includes vacation days, medical/personal days, and holidays.
    • Risk Management and Issue Resolution.
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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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