Product Specialist

**About us**

We are professional, agile, and our goal is to seek FDA approval for its lead thera-nostic product for the treatment of endotoxemic septic shock. PMX is a therapeutic hemoperfusion device that removes endotoxin, a main trigger of sepsis, from blood. Endotoxin Activity Assay (EAA), the only FDA cleared diagnostic for the risk of developing sepsis, directs the use of PMX. Spectral's TIGRIS trial is the world's only active Phase III study on septic shock..

Our work environment includes:

- Modern office setting
- On-the-job training

Spectral Medical is seeking FDA approval for its lead thera-nostic product for the treatment of endotoxemic septic shock. PMX is a therapeutic hemoperfusion device that removes endotoxin, a main trigger of sepsis, from blood. Endotoxin Activity Assay (EAA), the only FDA cleared diagnostic for the risk of developing sepsis, directs the use of PMX. Spectral's TIGRIS trial is the world's only active Phase III study on septic shock.

The Product Specialist will be responsible to ensure all clinical sites as part of a phase III FDA clinical trial are trained and equipped to use our medical devices in a safe and efficacious manner. Establish and maintain proper professional relationships with clinical trial sites and peers as well as performing necessary administrative duties as required and any other pertinent duties.

**Key Responsibilities**:

- Clinical Trial Support activities_

Product, Equipment, Instrument Maintenance

QMS Compliance
- Provide clinical trial site staff/customers with product training for diagnostic and therapeutic devices (on-site and remote).
- Provide technical support and troubleshooting assistance for clinical trial site staff/customers.
- Perform in-house installation, validation and, maintenance of products, related instruments and equipment.
- Ensure product, instrument, and equipment installation is performed according to QMS approved procedures and safety requirements.
- Perform product installation & implementation at clinical trial sites/customer sites.
- Maintain and coordinate logistics of products, equipment, and instruments.
- Collaborate with manufacturing and clinical trial teams to support installation and clinical site requirements.
- Ensure tools and test equipment are functional and calibrated.
- Receive and process product complaints from clinical trial sites/customers per company’s standard operating procedures and follow through resolution.
- Produce monthly and yearly product inventory reports.
- Participate in inventory management for clinical trials by monitoring inventory levels and re-ordering, replenishing and forecasting per business needs.
- Liaise with third-party logistics provider as required.
- Perform product related shipping duties and other in-house logistics functions as assigned.
- Ensure compliance of all administrative responsibilities such as training documents are up to date.
- Ensuring all training and product knowledge is kept up-to-date in line with current procedures.
- Meet health, safety and regulatory requirements.
- Contribute to internal product meetings and decisions.

**Requirements**:
Requirements/Qualifications
- Educational background with a Bachelor's degree, showing relevant qualifications in a science/engineering discipline
- Previous work experience in a safety critical environment; medical devices, dialysis and lab bench work experience is preferred but not essential.
- Previous work in a clinical trial setting.
- Excellent analytical, interpersonal and communication skills with the ability to train and instruct in an easy to understand manner.
- Experience in troubleshooting and responding to clinical trial sites/customers.
- Proficient level of computer skills including Word, PowerPoint, Excel and Outlook.
- Resourceful, with the ability to work independently.
- Strong time management skills.
- Decision making, problem resolution and creative thinking skills.
- Attention to detail.
- Able to work productively in a pressurized environment.
- Ethical and trustworthy.
- Flexible to travel across the US when required.

**Job Types**: Full-time, Permanent

**Salary**: $50,000.00-$70,000.00 per year

**Benefits**:

- Dental care
- Extended health care
- On-site parking

Schedule:

- Monday to Friday

**Experience**:

- Hemodialysis: 3 years (preferred)
- Clinical Laboratory: 3 years (preferred)
- Clinical Trials: 3 years (preferred)

Ability to Commute:

- Etobicoke, ON M9C 1C2 (preferred)

Work Location: Hybrid remote in Etobicoke, ON M9C 1C2