Quality Assurance and Regulatory Affairs Manager

Job Type: Full-time

Job Location: Ottawa, ON

We’re looking for a confident, proactive candidate to lead our Quality Assurance and Regulatory Affairs team.  You will drive continuous improvement and work to ensure compliance to global medical device regulations.  This is an opportunity to make a real impact on the world by furthering our mission to expand hearing healthcare around the globe with our innovative mobile and web-based medical solutions, and to work with an amazing (seriously, amazing) group of brilliant and passionate people.

Why we need you:

SHOEBOX is on the forefront of several trends – Software as a Medical Device, mobile apps, customers shifting to direct to consumer sales, Agile software development compliance with design controls requirements – it’s an exciting place to work!  

The ideal candidate thrives in a fast-paced environment, gathering available data to align quality and regulatory strategies with corporate objectives, and adjusting tactical plans as required to ensure top risks and priorities are addressed.  

We are growing really fast, and we need a strategic cross-team collaborator to ensure compliance and the effectiveness of our Quality Management System, and drive continuous improvement. You are a problem solver, adept at a risk-based approach to everything, and excited by new challenges. You are a strategic thinker, a collaborative master planner, and a happy do-er. 

Your primary responsibilities:

  • Maintain compliance of ISO 13485 Quality Management System (QMS) to US FDA, Health Canada, European MDR, and other global regulatory requirements.
  • Act as Management Representative for the QMS, leading management review process to ensure effective implementation of QMS.
  • Work with process owners to establish and monitor Quality Objectives Scorecard to assess organizational performance and focus continuous improvement efforts.
  • Manage key quality assurance processes: risk management, document control, records control, non-conforming material, customer complaints, corrective and preventive action, equipment calibration, supplier quality.
  • Work with Development to ensure our agile development process meets design and development and risk management requirements.
  • Manage the internal audit program and external audits and inspections.
  • Provide training to employees on aspects of the QMS that are relevant to their role.
  • Manage new and existing product and site regulatory registrations.
  • Monitor changes to regulations and standards, plan and execute required changes with other stakeholders.
  • Lead post-market surveillance process, assess events for reportability, manage recalls, and advisory notices.
  • Review & approve product labeling for compliance.
  • Provide management direction and supervision to a small team.

Qualifications:

  • Undergraduate degree in science, engineering, business or equivalent combination of relevant job experience, training, and knowledge.
  • Minimum 10 years experience in a Quality Management role, preferably in a medical device and software environment.
  • Demonstrated success in leading continuous improvement initiatives to achieve tangible business results.
  • Excellent analytical and problem-solving skills.
  • Effective in communicating and collaborating with all levels of the business ranging from the organization’s executives, developers, support, and sales.
  • Self-motivated, detail-oriented, responsible and timely team-player with excellent written, verbal, presentation, and collaboration skills
  • Comfortable in a fast-paced, high-energy, customer-focused start-up environment.

Assets:

  • Certified ISO 13485 internal auditor.

Who are we? We’re SHOEBOX Ltd. We design and develop audiometry products that are creating a seismic shift in the way hearing healthcare is provided. Utilizing iOS and web technology to replace bulky, expensive equipment, we’re bringing hearing testing into the 21st century and making it more affordable and accessible than ever before.

Why that’s important: 5% of the world’s population suffers from disabling hearing loss, 60% of childhood hearing loss is due to preventable causes, and the majority of people with disabling hearing loss live in low-middle income countries. We can help. With our products, hearing testing can be conducted outside of a sound booth and without the need for clunky equipment (you just need a calibrated headset and an iPad), which allows for testing almost anywhere, anytime, worldwide. 

At SHOEBOX, your contribution will have a meaningful impact every single day. On top of that, you’ll be an integral part of an innovative team, working with the latest tools and technologies, pushing the boundaries of what the Quality function can do, and collaborating with colleagues who are super passionate about their crafts. 

In joining us, you’re joining a dedicated and passionate team that works hard and cares deeply about the change we’re making in the world. We also take time to celebrate our successes, enjoy lunchtimes together, and genuinely like and care about one another. Also, our founder knows how to do magic tricks. It’s pretty cool. 

To learn more about us and what we stand for, read the SHOEBOX Audiometry story and our company and audiometry and hearing screening blog

We offer competitive salaries and benefits, real work-life balance, flexible hours, and a discretionary wellness benefit. SHOEBOX will provide you with a MacBook Pro with memory to spare and a 4K monitor. 

We invite enthusiastic and qualified applicants to submit their resume by email jobs@shoebox.md. Please include “Quality Assurance and Regulatory Affairs Manager” in the subject line. 

We thank all applicants; however, only those selected for an interview will be contacted. 

SHOEBOX is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. If you have a disability or special need that requires accommodation, please let us know.