About us

Trexo Robotics (Y Combinator Company) is enabling mobility by building powered wearable robots. Our first product is a robot for children with movement disorders such as Cerebral Palsy, and it allows kids to walk, in many cases, for the first time in their lives. The device is currently being used by hundreds of families and the best hospitals across North America.

We are constantly working towards building mobility solutions for all. At Trexo Robotics, you will find a flat organization where you can work with highly optimistic, low ego, and exceptionally talented individuals who look forward to solving hard problems.

Trexo's work doesn’t stop with children. We are working towards building mobility solutions for all. At Trexo Robotics, you will find a flat organization where you can work with highly optimistic, low ego, passionate and talented individuals who look forward to solving hard problems.

About the job

We are seeking a Clinical Research and Regulatory Associate who will be responsible for managing the day-to-day activities of one or more clinical trials as well as working on regulatory filings and activities. Reporting to the Director of Regulatory, Quality, and Clinical Affairs, the candidate will partake in activities including: developing clinical trial design and documentation, liaising with numerous parties including contracted vendors, global partners, clinical site personnel, and Trexo internal teams, monitoring the progress and conduct of ongoing trials, maintaining data quality, and managing clinical trial documentation and databases.

The Clinical & Regulatory Associate will be also be responsible for ensuring that all activities are conducted in compliance with the protocols, SOPs, ICH-GCP guidelines, and any applicable regulatory requirements. The candidate will also participate in regulatory filing activities (eg. obtaining regulatory licence approvals and clearances), review of documentation for regulatory submissions, and problem reporting or recall activities.

This position is hybrid (3 days in our office in Mississauga).

About you

You want to work in a small team solving a big problem. You are excited by the prospect of revolutionizing multiple industries. You can juggle many tasks simultaneously. You are detail-oriented and love asking why many times till you understand something from first principles.

You will leverage their superior critical thinking and communication skills, as well as your adaptability and resourcefulness to ensure the ongoing success of Trexo's research and regulatory initiatives.

What you'll do

• Assist in designing clinical trials, including developing study protocols, informed consent forms, and case report forms (CRFs). This involves collaborating with clinical, regulatory, and medical teams to ensure that the study objectives are clearly defined and feasible.

• Identify, evaluate, and select clinical trial sites. This includes conducting site feasibility assessments and working with site staff to ensure they have the necessary resources and training to conduct the trial.

• Ensures ethics approval is obtained and clinical trial contracts are signed, as required.

• Ensures that all trial activities are conducted in accordance with the trial protocol, all applicable regulations, guidelines, local laws and Trexo procedures.

• Provide training and support to site staff on the study protocol, data collection procedures, and regulatory requirements.

• Assist with development and execution of monitoring plans. Regularly visit clinical trial sites to monitor the progress of the study. This includes checking that the trial is being conducted according to the protocol, regulatory requirements, and good clinical practice (GCP) guidelines.

• Monitor and report any adverse events or safety issues that arise during the trial. Ensure that there are appropriate procedures in place for the timely reporting and management of adverse events.

• Coordinates the collection, delivery, entry, verification, and management of clinical trial data.

• Maintain and organize study documentation, including monitoring reports, site visit notes, and correspondence. Ensure that all documentation is accurate, complete, and readily available for audits and inspections.

• Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up; assembles necessary documents, conducts site termination visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study termination reports.

• Act as a liaison between the study sponsor, clinical sites, and other stakeholders. This involves regular communication to update all parties on study progress, address any issues, and facilitate the smooth operation of the trial.

• Ensure that medical devices meet all regulatory requirements set by agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), or other international bodies. This involves understanding and interpreting regulations and guidelines.

• Prepare, review, and submit regulatory documents, such as product registrations, technical files, and clinical trial applications. This includes compiling data and ensuring all necessary information is accurately presented.

• Manage and coordinate the submission process for regulatory approvals, including premarket notifications (510(k)), Health Canada approvals, and CE markings, depending on the market.

• Ensure that labeling and promotional materials comply with regulatory standards. This includes reviewing product labels, packaging, and advertising to ensure they meet required guidelines.

• Work with other teams, such as R&D, quality assurance, and marketing, to ensure that regulatory requirements are integrated into the product development process and to address any compliance-related issues.

• Contribute to the development of regulatory strategies for new products or markets. This may involve strategic planning to meet regulatory requirements efficiently and effectively.

• Develop departmental working guidelines to document standard processes in the department.

• Assists with quality management activities, as required

• Performs miscellaneous job-related duties as assigned.

Required Skills and Experience

• At minimum, a Bachelors degree, or recognized equivalent, in a health or science-related discipline.

• 1+ years of prior regulatory experience in medical devices and/or ISO 13485/ISO 9001 regulated companies.

• 1+ years of prior clinical research experience in medical device or pharma.

• Familiarity with clinical trial phases, design, and methodologies. Understanding of clinical research protocols and good clinical practice (GCP) guidelines.

• Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment.

• Ability to identify and resolve issues that arise during the trial, including protocol deviations or data inconsistencies.

• Strong attention to detail for reviewing data, ensuring accuracy, and identifying discrepancies or issues.

• Must be fluent in English and posses solid writing abilities.

• Strong Proficiency with MS Office software, Word, Excel, Google Suite.

• Excellent communication skills (interpersonal, written, and verbal).

• Effective time management skills to handle multiple tasks, prioritize responsibilities, and meet deadlines.

• Strong ethical standards and a commitment to maintaining the confidentiality and integrity of clinical research.

• Ability to adapt to changing conditions and requirements in a fast-paced research environment.

• Ability to work effectively as part of a team while also being able to work independently.

Nice to Have

• Postgraduate certificate in Clinical Research (eg. SOCRA, ACRP) and/or RAC, strongly preferred.

• Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards.

• Experience working on FDA or Health Canada regulated clinical trials, an asset.
  

Compensation and Benefits

• Competitive pay and employee stock options.

• Unlimited Vacation policy.

• Group benefits plan (in 100% covered by the company).

• Snacks in the office.

• Dog friendly office.

Please note that at this time, we can only consider applicants who are already eligible to work in Canada and we are unable to provide relocation support. We appreciate your understanding and look forward to receiving your application.