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Added 6 mins ago
BR
AEM Developer with React
BULLIT RECRUITMENT SOLUTIONS LIMITED
Toronto, ON
- Full-time
We are currently looking for a Digital Developer to work within our Digital Development team. The successful candidate will be a key member who will work with UX, UI, Business stakeholders…
Added 6 mins ago
GS
Product Designer
GG Studio
NB · Chiasson Office, NB
- Full-time
At GG, we believe that building great products starts with great people. That’s why we’re always on the lookout for down-to-earth, independent thinkers who know how to work well in a team.
Added 6 mins ago
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Business Systems Developer
Grantek
Burlington, ON
- Full-time
Grantek is looking for a Business Systems Developer to design, build, and maintain the internal applications, integrations, and automation workflows that support our global operations. This…
Added 10 mins ago
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Chef principal(e), Publicité numérique chez les détaillants – Nutrition (Montréal)
Abbott
Montreal, QC
- Full-time
Added 10 mins ago
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Acoustic Engineer (Canada)
Ehvert Engineering a Salas O'Brien company
Remote, Canada
- Full-time
- Remote
…seeking an experienced Acoustic Engineer to join our growing team, with a primary focus on delivering complex mission-critical projects, including hyperscale and enterprise data centre…
Added 10 mins ago
Technical Architect Contracts (Computer Services Officer 4)
The Government of Nova Scotia
Halifax, NS
At CSDS, we prioritize people - both within our team and in the communities we serve. Our mission is to redefine how Nova Scotians engage with government by creating accessible, reliable…
Added 10 mins ago
Senior Manager, Store Experience & Services
Sephora
Toronto, ON
…and client satisfaction. You’ll be part of a collaborative team that’s united in beauty and supported by partners across Retail, Marketing, Finance, Talent & Training, Digital, Brand…
Added 10 mins ago
Manager, ISI Office & Programs
University of Toronto
Toronto, ON
…leadership for the ISI portfolio. Working through and alongside a team of staff, the Manager builds the systems, processes, tools and practices that enable a portfolio of complex…
Added 10 mins ago
Teaching Labs Coordinator
University of Toronto
Toronto, ON
Supporting program administration and communications, including responding to enquiries, maintaining records and digital platforms, tracking student enrollment, and coordinating outreach…
Added 10 mins ago
Performance & Delivery Manager - Industrial Operations
Alstom
Toronto, ON
…to turnkey systems, services, infrastructure, signalling and digital mobility, we offer our diverse customers the broadest portfolio in the industry. Every day, more than 80 000 colleagues…
Added 10 mins ago
Service Lead
Burberry
Vancouver, BC
Daily floor supervision of sales team ensuring great customer experiences and thereby driving sales goal attainment and providing real-time performance coaching to drive the overall…
Added 10 mins ago
Operations Supervisor
Burberry
Vancouver, BC
To provide leadership for the store, setting an excellent standard for the store and inspiring the team to achieve it.
Added 22 mins ago
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AI Solutions Architect
Hays
Toronto, ON
- Contract
Our client is a leading financial services organization undergoing significant digital transformation initiatives across enterprise data, AI, banking integration, risk, finance, treasury,…
Added 22 mins ago
RF
Program Coordinator
RISC Foundation (Risk and Insurance Studies Centre)
Toronto, ON
- Contract
We are seeking a motivated and qualified individual to join our team in a full-time, hybrid position as Program Coordinator for the Risk Education and Literacy (REaL) program, which is an…
Added 22 mins ago
HM
Bilingual Commercial / Leasing Paralegal Ottawa, Cieslok Group
Hire Mint
Toronto, ON
- Full-time
CIESLOK is a premium out-of-home advertising company that operates iconic digital and static inventory across Toronto, Montreal, Ottawa, and Edmonton on sites we lease from landlords and…
Added 22 mins ago
HT
IT Internal Auditor
Husky Technologies
Bolton, ON
- Full-time
…offers an opportunity to work with – and be challenged by – a team of great people. Our success is possible because of the creativity, intelligence and passion of our people around the…
Added 22 mins ago
HT
Internal Auditor (Business Control & IT)
Husky Technologies
Bolton, ON
- Full-time
…offers an opportunity to work with – and be challenged by – a team of great people. Our success is possible because of the creativity, intelligence and passion of our people around the…
Added 22 mins ago
VC
Adobe Experience Manager (AEM), SRE - CDN and Edge Delivery
VK CONSULTING SERVICES
Canada
- Full-time
RBC is building a net-new enterprise content management and digital asset management platform from the ground up, delivering the public web experiences on Adobe Experience Manager - Edge…
Added 22 mins ago
AI
Accounts Payable Manager
American Iron & Metal (AIM)
Montreal, QC
- Full-time
Become part of team AIM, a growing team with an entrepreneurial spirit who has over the years evolved into a successful and multifaceted company with business divisions that include metal…
Added 25 mins ago
DC
Intermediate/Senior Noise Engineer
Dillon Consulting Limited
Calgary, AB · Edmonton, AB
- Full-time
We are currently seeking a Intermediate/Senior Noise Engineer to join our Atmospheric Services team. Our team specializes in in the atmospheric and acoustic solutions that safeguard both…
Added 25 mins ago
DC
Intermediate/Senior Air Quality Engineer
Dillon Consulting Limited
Calgary, AB · Edmonton, AB
- Full-time
We are currently seeking a Intermediate/Senior Air Quality Engineer to join our Atmospheric Services team. Our team specializes in in the atmospheric and acoustic solutions that safeguard…
Added 25 mins ago
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Sr. Community Developer - Far Cry
Ubisoft
Montreal, QC
- Full-time
The Senior Community Developer is a leader in creating global community engagement strategies that support player retention inside & outside of their experiences with our games. They will…
Added 25 mins ago
SC
Member Experience Advisor - Grande Prairie
Servus Credit Union
Grande Prairie, AB
- Full-time
We’re looking for passionate, values-driven people to join our team. We welcome individuals from all backgrounds who are aligned with our values and are eager to contribute in meaningful…
Added 25 mins ago
Technical Lead - Infrastructure
BitGo
Toronto, ON
BitGo (NYSE: BTGO) is the digital asset infrastructure company delivering custody, wallets, staking, trading, financing, stablecoins, and settlement services from regulated cold storage.…
Added 25 mins ago
Engineering Manager - Infrastructure
BitGo
Toronto, ON
BitGo (NYSE: BTGO) is the digital asset infrastructure company delivering custody, wallets, staking, trading, financing, stablecoins, and settlement services from regulated cold storage.…

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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