Research Assistant Regulatory Associate

**About Western**:
**About Us**:
With a strong focus on teaching, research and clinical service, the Department of Pathology and Laboratory Medicine fully supports the mission and values of the Schulich School of Medicine & Dentistry, Western University, the London Health Sciences Centre and St. Joseph’s Health Care London. Our vision is to provide state-of-the-art diagnostic pathology services while achieving excellence in pathology research, training and education. The members of the Department of Pathology and Laboratory Medicine strive to provide a quality work environment that fosters unity, respect for diversity, teamwork and professional growth.

**Responsibilities**:
The Research Assistant Regulatory Associate will support the research activities for qualitative and quantitative projects in adherence with ethics protocols and guidelines. The incumbent will handle the day-to-day research duties required for the operation of the laboratory or research centre, and may be a liaison between the research team and study participants. The incumbent will assist in the dissemination of research results arising from these projects, and perform qualitative and quantitative data collection, entry and processing. The Research Assistant may also assist with the preparation of any required documents, coordinate travel, and organize meetings for the research team. The Research Assistant Regulatory Associate (Industry Collaborative Role) will carry out the following responsibilities in Dr. Matthew Cecchini and Dr. Saumik Biswas's Team:
**Regulatory Affairs**:

- Assist with FDA and Health Canada research and document drafting
- Support the development of regulatory strategies, including expansion into new markets (e.g., Middle East, Europe, and others)
- Collaborate with regulatory consultants on ongoing regulatory related projects as needed
- Assist the industry partner in preparing for regulatory meetings, creating relevant regulatory/QMS-related materials, and managing communications with potential stakeholders where appropriate

**Quality Management System (QMS)**:

- Collaborate with QMS implementation consultants on ongoing QMS related implementation and maintenance projects as needed
- Collaborate with engineering and software teams to draft, maintain, and review QMS-related documents
- Ensure traceability of software specifications and compliance with medical device quality standards

**Clinical Coordination**:

- Coordinate with collaborators to collect, manage, and analyze clinical and experimental data
- Support onsite clinical experiments, when appropriate, and ensure alignment with regulatory and study requirements

**Data Management**:

- Organize and analyze data collected from clinical studies to support regulatory and product development goals
- Ensure proper data traceability and secure storage

**Stakeholder Engagement**:

- Collaborate with internal and external teams to ensure seamless communication and project alignment
- Prepare reports summarizing clinical and regulatory progress for the executive team
- Qualifications

**Education**:

- Undergraduate degree in a life science, engineering, or healthcare-related field (advanced degree preferred)

**Experience**:

- 2 years of experience in regulatory affairs training or clinical coordination within the medical device or healthcare industry

Skills, Abilities & Expertise:

- Knowledge of FDA, Health Canada, and EU regulatory requirements and standards
- Familiarity with clinical study coordination, data management, and QMS implementation
- Strong attention to detail, organizational skills, and the ability to work in a dynamic startup environment
- Detail-oriented with an ability to function and process information with high levels of accuracy
- Ability to employ a systematic and efficient approach to work
- Personable and courteous in working relationships with colleagues, students and the public
- Ability to collect and analyze data in an objective manner
- Familiarity with regulations and guidelines governing research
- Familiarity with methods for research design, implementation, and analysis
- Familiarity with experimental design and analysis
- Computer skills with the ability to learn and use software programs
- Intermediate computer skills in Microsoft Office Suite
- Ability to work independently and effectively as a member of the team to achieve department goals
- Verbal and written communication skills with the ability to document technical information

**Why Western?**:
Consideration of applicants will include an assessment of previous performance, experience, and qualifications. Applicants should have oral communication skills in English.

**Western Values Diversity**:
Accommodations are available for applicants with disabilities throughout the recruitment process. If you require accommodations for interviews or other meetings, please contact Human Resources or phone 519-661-2194.

**Please Note**:
We thank all applicants for their int