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Added 2 hours ago
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Research Associate
RI-MUHC | Research Institute of the MUHC | #rimuhc
Montreal, QC
- Full-time
The MyeliNeuroGene Research Laboratory, directed by Dr. Genevieve Bernard, MD, MSc, a clinician-scientist, is looking for a motivated person to fill the position of full-time Research…
Added 2 hours ago
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Project Manager, Capture and Optimization of Research Data (CORD) Platform
RI-MUHC | Research Institute of the MUHC | #rimuhc
Montreal, QC
- Full-time
The Research Institute of the MUHC is seeking an interim Project Manager to join the Capture and Optimization of Research Data (CORD) platform of the Centre for Outcomes Research and…
Added 5 hours ago
Investment Team Associate
ONCAP
Toronto, ON
ONCAP is seeking a highly motivated Associate to join its investment team in Toronto. This role offers the opportunity to work across the full investment lifecycle, from origination through…
Added 6 hours ago
TO
Philanthropy Operations Associate
The Ottawa Hospital Foundation
Ottawa, ON
- Full-time
Philanthropy Operations Associate, Donor Recognition and Stewardship
Added 6 hours ago
Associate Portfolio Manager | Ongoing Opportunities
Sonance Wealth Partners
Ottawa, ON · Edmonton, AB · Lethbridge, AB
We welcome expressions of interest from early-career investment professionals seeking future Associate Portfolio Manager opportunities across Sonance Financial’s Partner Groups. This is an…
Added 9 hours ago
LC
Associate Faculty - Clinical Nursing
Lambton College
Sarnia, ON
- Part-time
We are providing our students with the best learning and research experiences to ensure they are well-equipped to contribute to, and thrive in, a world of opportunity.
Added 10 hours ago
LC
Merchant, Hard Discount
Loblaw Companies Limited
Brampton, ON
- Full-time
…in-store merchandising strategies, working in coordination with Associate Merchants, Space Planners, and Supply Chain…
Added 11 hours ago
G
Part Time Sales Associate - Vaughan Mills
Geox
Vaughan, ON
- Part-time
…to changing and improving . We identify , through constant research , the most advanced technologies and the latest trends , so that we can eventually incorporate them in our unique…
Added 11 hours ago
TH
Assistant Professor-Nursing
The Honor Society of Nursing, Sigma Theta Tau International
Toronto, ON
- $130,000 to $150,000 CAD / year
- Full-time
This position is being advertised concurrently with the full-time tenure stream position in Nursing at the rank of Associate Professor (ID: 50146). To be considered for the full-time tenure…
Added 14 hours ago
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Clinical Research Manager
RI-MUHC | Research Institute of the MUHC | #rimuhc
Montreal, QC
- Full-time
Do you want to work for a world-renowned research institute that pushes the boundaries of biomedical science and health research? Right here in Montreal! At the Research Institute of the…
Added 14 hours ago
R|
Research Associate
RI-MUHC | Research Institute of the MUHC | #rimuhc
Montreal, QC
- Full-time
The MyeliNeuroGene Research Laboratory, directed by Dr. Genevieve Bernard, MD, MSc, a clinician-scientist, is looking for a motivated person to fill the position of full-time Research…
Added 14 hours ago
R|
Project Manager, Capture and Optimization of Research Data (CORD) Platform
RI-MUHC | Research Institute of the MUHC | #rimuhc
Montreal, QC
- Full-time
The Research Institute of the MUHC is seeking an interim Project Manager to join the Capture and Optimization of Research Data (CORD) platform of the Centre for Outcomes Research and…
Added 18 hours ago
GE
Program Director, Psychiatric-Mental Health Nurse Practitioner (PMHNP), Associate Professor or Professor on the Educator Track, BSON – Georgetown University Medical Center
Georgetown Executive and Clinical DNP Programs
Georgetown, ON
- Full-time
Program Director, Psychiatric-Mental Health Nurse Practitioner (PMHNP), Associate Professor or Professor on the Educator Track, BSON - Georgetown University Medical Center
Added 19 hours ago
SG
Associate Director – Non-Bank Financial Institutions, New York City, Denver or Toronto
S&P Global
Toronto, ON
- Full-time
Contribute market-facing research and insights that help investors, issuers, and other stakeholders understand evolving credit risks.
Added 1 day ago
KM
Senior Tax Associate
KF Matheson Investment Holdings
Mississauga, ON
- Full-time
Reporting to the Senior Manager, Tax, the Senior Tax Associate will be an integral part of the Finance team and will be responsible for supporting tax compliance, reporting, planning…
Added 1 day ago
NG
Desktop Support Engineer (Level 2)
NSC Global
Brantford, ON
- Other
…including rights, security and systems groups. May require an associate’s degree in a related area or 5+ years of experience in the field or in a related area. Familiar with a variety of…
Added 1 day ago
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Technology Strategy & Transformation, Senior Associate
PwC
Toronto, ON
- Full-time
As a Technology Strategy & Transformation, Senior Associate, unlock your potential and embrace the chance to drive meaningful outcomes that’ll elevate your career. We are seeking candidates…
Added 1 day ago
LF
Full Time Showroom Associate
Leons Furniture Limited
Barrie, ON
- Full-time
Computer work – use operating system to research product information, prices and specs
Added 1 day ago
LV
Associate Category Manager
Lee Valley Tools
Ottawa, ON
- $60,000 to $75,000 CAD / year
- Full-time
The Associate Category Manager plays a vital role in delivering compelling and innovative products that resonate with our customers and drive business performance. This position supports…
Added 1 day ago
T
User support technician
Tech-Eyes
Edmonton, AB
- From $33.19 CAD / hour
- Full-time
- On-site
Consult user guides, technical manuals and other documents to research and implement solutions
Added 1 day ago
FP
Shipping and Freight Associate
Fresh Prep Foods Inc
Victoria, BC
- Up to $22 CAD / hour
- Part-time
Research shows that while men apply to jobs when they meet an average of 60% of the criteria, women and other marginalized folks tend to only apply when they check every box. So if you…
Added 1 day ago
GB
Executive Associate to the General and Artistic Director
Goh Ballet Canada
Vancouver, BC
- Full-time
…we are seeking an exceptional individual to become a trusted associate to the General and Artistic…
Added 1 day ago
WM
Associate Director, Fundraising
Windmill Microlending
Calgary, AB · Toronto, ON
- $110,000 to $120,000 CAD / year
Windmill Microlending is seeking a collaborative and dynamic self-starter to serve as our Associate Director, Fundraising as we prepare to close an exciting $50M national campaign that…
Added 1 day ago
GC
Warehouse Associate
Grimco Canada Inc.
Edmonton, AB
- $21 to $23 CAD / hour
The Warehouse Associate is an integral part of the team, responsible for ensuring the smooth and efficient operation of the warehouse. This role involves handling a wide range of tasks,…
Added 1 day ago
ST
Financial Business Services Coordinator
Securitas Technology Canada Corporation
Mississauga, ON
- Full-time
…Specific duties or tasks may vary and be documented separately. An associate might or might not be required to perform all functions listed. Additional duties may be assigned, and functions…

Exquisite Biomedical Consulting

Regulatory Affairs Associate

Vancouver, BC, Canada

Part-time

Apply About employer

Applications open in a new tab.

Job details

Job type: Part-time
Apply by: Nov 8, 2026
Experience: 4+ years of regulatory affairs experience in medical devices or related life sciences products.
Posting language: English
Posted: Oct 9, 2026

Original job description

About the Company

Exquisite Biomedical Consulting (EBC) is a boutique life sciences consultancy firm specializing in Medical Affairs, Clinical and Regulatory Strategy, and Evidence Generation for medical device, regenerative medicine, diagnostics, and digital health companies.

We partner with life sciences manufacturers from concept through commercialization of novel medical products and offer services such as fractional Chief Medical Officer, medical, clinical and regulatory strategy, literature and evidence development, medical writing, and business development. Our clients range from small to midsize enterprise, start-ups and corporations in different therapeutic areas.

Role Overview

The Regulatory Affairs Associate supports EBC's clients with regulatory strategy, submissions, and lifecycle documentation for medical devices and related life sciences products. You'll turn regulatory requirements into clear plans and practical deliverables across different technologies, therapeutic areas, and development stages, and across frameworks including Health Canada, US FDA, and EU MDR.

You'll assess requirements, identify gaps, coordinate subject matter experts, prepare accurate documentation, and lead client interactions, escalating when additional or external input is needed. You'll report to the CEO and work closely with EBC's team and clients. Workload and scope vary with client needs and may include work beyond regulatory affairs, as well as internal EBC projects.

Key Responsibilities

Advise clients on regulatory needs and high-level strategy.
Develop regulatory strategies, assess product classification and pathways, and identify documentation requirements and gaps.
Prepare and review submissions and technical documentation with expert input.
Write regulatory documents, including EU MDR clinical evaluations and Clinical Study Reports.
Coordinate client-approved communications with regulators and notified bodies.
Monitor regulations, guidance, and standards, and advise the team and clients on their implications.
Ensure document accuracy and consistency, follow EBC and client procedures, and keep clear records.
Manage client projects, meet deadlines, and communicate progress and issues promptly.
Escalate when additional or external input is required.
Contribute to internal EBC projects and support the company's growth.
Protect confidential information and maintain professional, ethical conduct.

Qualifications

Must have

Bachelor's degree or higher in a science, engineering, or health field (master's or PhD preferred).
4+ years of regulatory affairs experience in medical devices or related life sciences products.
Working knowledge of FDA, Health Canada, EU, and international regulatory frameworks.
Strong writing, presentation, and negotiation skills, with the ability to turn dense regulatory text into clear business steps.
Experience preparing and reviewing regulatory documentation and coordinating input from clinical, quality, engineering, and other teams.
Familiarity with quality procedures and medical device lifecycle requirements.
Permanent authorization to work in Canada.

Nice to have

Experience with Health Canada device license applications, US FDA submissions, or EU MDR technical documentation.
Experience writing CEPs, CERs, SSCPs, PMS, PMCF, PSURs, or similar documents.
Clinical trial regulatory documentation experience.
Familiarity with ISO 13485, ISO 14971, MEDDEV and MDCG guidance, and other relevant standards.
Background in diagnostics, digital health, regenerative medicine, pharmaceuticals, or consulting.

Skills and Competencies

Regulatory research, analytical thinking, and problem-solving.
Clear writing, editing, presentation, and quality control; proficiency in Microsoft Office.
Professional, confident, and discreet in client interactions.
Organized, dependable, and responsive, with a sense of urgency.
Self-motivated and adaptable to shifting workloads and priorities.
Collaborative and willing to take on varied assignments.

What We Offer

Meaningful regulatory, clinical, and evidence-generation work at a growing boutique life sciences consultancy.
Exposure to innovative medical device, biotech, diagnostics, and healthcare projects.
A flexible, entrepreneurial environment.
Collaboration with experienced professionals across disciplines.
The chance to shape EBC's growth and effectiveness.

Apply About employer

More about this job

Responsibilities

Advise clients on regulatory strategy, product classification, pathways, documentation requirements, and gaps across FDA, Health Canada, and EU frameworks. Prepare and review regulatory submissions and technical documents, coordinate client and expert input, monitor regulatory changes, manage project delivery, and contribute to internal company initiatives.

Requirements

Requires a bachelor's degree or higher in a science, engineering, or health field, with a master's degree or PhD preferred, and at least four years of regulatory affairs experience in medical devices or related life sciences products. Candidates must have working knowledge of FDA, Health Canada, EU, and international frameworks, strong documentation and communication skills, relevant cross-functional experience, and permanent authorization to work in Canada.

Skills

Regulatory Strategy
Regulatory Submissions
Regulatory Research
Medical Device Classification
Regulatory Pathway Assessment
Technical Documentation
Clinical Evaluation
Clinical Study Reports
Regulatory Writing
Project Management
Client Communication
Quality Control
FDA Regulations
Health Canada Regulations
EU MDR
ISO 13485

Benefits

Flexible Work Environment
Cross-Disciplinary Collaboration
Exposure to Innovative Projects

Visa sponsorship

Not detected in the job text

Keywords

Medical Devices
Life Sciences
Regulatory Affairs
Regulatory Strategy
FDA
Health Canada
EU MDR
International Regulatory Frameworks
Regulatory Submissions
Technical Documentation
Clinical Evaluation Plans
Clinical Evaluation Reports
Summary of Safety and Clinical Performance
Post-Market Surveillance
Post-Market Clinical Follow-Up
Periodic Safety Update Reports
Clinical Study Reports
Clinical Trial Regulatory Documentation
ISO 13485
ISO 14971
MEDDEV
MDCG Guidance
Quality Procedures
Medical Device Lifecycle
Regulatory Research
Microsoft Office
Diagnostics
Digital Health
Regenerative Medicine

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