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.
