Regulatory and Clinical Affairs Manager
The Manager, Clinical and Regulatory Affairs will be responsible for obtaining and maintaining worldwide marketing and clinical use permissions in a regulated environment. Working closely with the team members from the departments of product development, technology, operations, and sales & marketing, the Manager Regulatory Affairs will perform all day-to-day tasks associated with filing and maintaining market clearance for new and existing products. In the role of Manager Clinical Affairs, the position will involve the management and conduct of Zephyr clinical investigations and participating in other research- and data-related activities of the Technology Department.
- Supports the planning, implementation, and development of regulatory strategies for products that require government approval
- Prepares and submits new applications for market authorization to the regulatory authorities
- Monitors new regulations to assist in planning for changes impacting the Quality system and/or product
- Maintains device registrations, establishment registration, technical files, and device listings for all jurisdictions
- Acts as the chair of the Recall and Withdrawal Committee and leads investigations as required
- Manages all aspects of Unique Device Identification and medical device reporting
- Determines the need for, plans, prepares, and submits appropriate applications required for investigational testing
- Maintains and manages clinical trial data in compliance with the protocol and requirements of the regulatory bodies and ethics review board
- Ensures that clinical research and related activities are performed in accordance with Federal and regional regulations as well as those of Zephyr and co-sponsoring companies’ policies and procedures, including the maintenance of clinical trial registries and PHI
- May function as or supervise Clinical Coordinators, a role that includes screening individuals for study eligibility; coordinating tests and procedures; collecting data as required by the protocol; entering data in data repositories and performing analysis as required; maintaining study timelines and adequate inventory of study supplies; maintaining effective and ongoing communication with research participants, PIs, and co-sponsors during the course of the study; and maintaining study timelines and budgets.
EXPERIENCE AND QUALIFICATIONS
- 2+ years of regulatory experience (Medical or Health strongly preferred)
- Previous experience with clinical study management and conduct
- Prior experience interacting with clinical study participants preferred
- Ability to enter in-progress clinical trials seamlessly
- Experience working in high growth environments
- Excellent verbal and written communication skills
- Strong organizational skills
- Ability to efficiently work with large spreadsheets and data sets
- A team player, with a desire to work in an entrepreneurial work environment
- A strong interest in medical device development
- Knowledge of GCP and ISO 14155
- Graduate degree (Medical, Health or Sciences is preferred)
ABOUT ZEPHYR SLEEP TECHNOLOGIES
Zephyr Sleep Technologies (“ZST” or the “Company”) designs, develops and manufactures medical devices for diagnosis and treatment of sleep disordered breathing. Zephyr has launched its second generation product, the MATRx Plus, designed to fulfill the needs of a significant and expanding market in the US. The MATRx Plus is a tablet-based and cloud-connected medical device designed to be used at the patient’s home and is currently cleared by Health Canada for sale in Canada and by the US Food and Drug Administration (FDA) for sale in the US. The MATRx Plus medical device is used to complete a two-night home study which determines: i) If a simple oral appliance is capable of treating obstructive sleep apnea (“OSA”; and, ii) a therapeutic position for the mandible. This information allows a dentist to custom make an oral appliance for an OSA patient.
Zephyr Sleep Technologies was founded in 2010 principally by Paul Cataford (CEO), John Remmers (Chief Medical Officer) and Sabina Bruehlmann (Director – Technology) and was spun out of the University of Calgary. Zephyr is a private company headquartered in Calgary Alberta with 36 employees. The intent is to grow the team to 55 by the end of 2019 Since inception, the Company has raised over $17 million – $6.7 million from investors and over $10 million from non-dilutive sources (government & strategic partners).
Partnership with DENTSPLY SIRONA (“D/S”)
On June 30, 2017 ZST closed a strategic investment with Dentsply Sirona (“D/S”), the largest dental technology company in the world. In addition to the investment, D/S is also “bundling” a MATRx Plus with each of its 3D AI – cone beam CT scanners in the US.
The MATRx is installed in 200 sleep labs and clinics in NA and over 12,000 tests have been completed since 2013. MATRx users include Kaiser Permenante in northern CA. The MATRx Plus has cleared Health Canada since the beginning of the year and is installed in close to 50 sites so far in Canada. The Company is now cleared by the FDA to sell the MATRx Plus in the US and has backlog of over $1 million. The plan is to be in 3,000-5,000 dentist offices by the end of 2020 bringing in annual revenues in excess of $35 million.
Keep it Simple
To help people live healthy and productive lives by sleeping better
- Do it right
- Find a way
- Work as a team
- Continually improve
- Be agile – work fast, smart and hard
If you would like to be a part of the Zephyr Sleep Technologies Team and you are interested in this exciting career opportunity, please apply via Indeed by clicking here. The position will remain open until it is filled. We thank all applicants for their interest; however only candidates selected for an interview will be contacted.