Quality Assurance and Regulatory Affairs Analyst

4 weeks ago

Kitchener ON, Canada Intellijoint Surgical Inc. Full time

Contribute towards safe and effective products at a fast-growing medical technology company

Type of Position: Full Time

Location: Kitchener HQ – In office presence required 3-days per week

Benefits: RRSP with employer match, health benefits (effective day-1), wellness benefit, learning & development opportunities, paid vacation, personal days, and sick days

The Company

Intellijoint Surgical develops effective and easy-to-use products to enhance surgeons’ care and patients’ lives. Today, Intellijoint technology lives in the operating room, helping surgeons improve implant positioning during hip and knee replacement surgeries. Our technology has been used in over 55,000 surgeries. We are seeking a Quality Assurance & Regulatory Affairs (QARA) Analyst to join our QARA team to help bring innovative technologies to the market.

The Position

As part of the Quality Assurance and Regulatory Affairs (QA/RA) Team, the QA/RA Analyst plans and implements quality assurance and regulatory affairs activities required for timely completion and sale of Intellijoint Surgical medical devices in a regulated environment. As an integral member of the team, the QA/RA Analyst collaborates with internal and external parties, ensuring compliance with our internal Quality Management System (QMS) requirements.

As a snapshot, we are looking for someone who:

  • Thrives in a policy and procedural driven environment; detail oriented, organized and diligent in adherence to policies and procedures
  • Nimble to adjust to priority tasks as they arise
  • A continuous learner that builds on their existing knowledge of medical device and biomedical technology regulations
  • Effectively communicates both written and verbal; clear, concise and responsive
  • Thoughtful approach to decision making with high agency

Main Duties:

  • Support product design, development and production via risk management, analysis, compliance, stakeholder engagement and process excellence.
  • Act as a key stakeholder and liaison with regulatory bodies in the submission of regulatory documents required for product approval and registration in various markets.
  • Conduct comprehensive regulatory impact assessments for product changes, ensuring continuous compliance with international standards such as MDSAP, FDA QSR, EU MDR, etc.
  • Contribute to and lead the development and improvement of internal processes and the quality management system by participating in audits, implementing advanced metrics, and analyzing data for continuous quality and regulatory enhancement.
  • Lead the review and approval process for more complex product records and quality documentation, ensuring compliance with specified requirements.
  • Contribute to the development and improvement of internal processes and the quality management system by participating in audits, implementing advanced metrics, and analyzing data for continuous quality and regulatory enhancement.
  • Collaborate with the supply chain team to qualify suppliers, conduct audits, and ensure suppliers meet the required quality and regulatory standards.
  • Conduct post-market surveillance activities, analyzing data from various sources (customer feedback, complaints, field reports) to identify potential product issues or trends, in line with regulatory requirements.
  • Coordinate the investigation and reporting of adverse events or other reportable incidents to regulatory authorities in compliance with global regulations.

Skills and Experience to Enable Success:

  • Bachelor’s degree in a related field is required; a postgraduate certification in Regulatory Affairs and/or Quality Assurance is highly advantageous.
  • 3+ years of relevant experience in a regulated industry, with a strong focus on medical devices.
  • Demonstrated experience in regulatory submissions, quality system management, and compliance with international medical device regulations and standards.
  • Strong analytical skills, with the ability to interpret regulatory guidelines and integrate them into business processes.
  • Proficient in using industry-standard software and systems, with a keen ability to adapt to new technologies.
  • Strong communication skills, capable of effectively collaborating with diverse teams and championing compliance across the organization.

Why join us?

  • It is unrealistic for us to believe we will find someone who fits this position 100% - interested? Apply
  • Strong support towards career development and growth
  • Work on innovative products that improve surgical outcomes and enhance patient’s quality of life.
  • Work alongside a highly talented and driven group of team members and colleagues’ organization wide.
  • Work in an environment with high transparency and collaboration along with lots of fun and social activities.
  • Be ok with change and share in our excitement as we scale.
  • Flexibility so that you can do your best both at work and outside of it.

Intellijoint Surgical is committed to creating an accessible and inclusive work environment. It is our policy to recruit and select applicants solely on the basis of their qualifications. We are an equal opportunity employer that hires talent regardless of age, race, creed, colour, religion, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, or any other status or condition protected by applicable law.

Intellijoint Surgical encourages applications from all qualified candidates. Those in need of accommodation at any stage in the recruitment process should notify hr@intellijointsurgical.com. Any information received that relates to accommodation needs of a candidate will be addressed in a confidential manner.

  • Quality Assurance

    3 weeks ago

    Kitchener, ON, Canada Intellijoint Surgical Inc Full time

    Quality Assurance & Regulatory Affairs Analyst Contribute towards safe and effective products at a fast-growing medical technology company! Type of Position: Full Time Location: Kitchener HQ – In office presence required 3-days per week RRSP with employer match, health benefits (effective day-1!), wellness benefit, learning & development...

  • Quality Assurance

    4 weeks ago

    Kitchener, Canada Intellijoint Surgical Full time

    **Tagline**: Contribute towards safe and effective products at a fast-growing medical technology company! **Type of Position**: Full Time **Location**: Kitchener HQ - In office presence required 3-days per week **Benefits**: RRSP with employer match, health benefits (effective day-1!), wellness benefit, learning & development opportunities, paid vacation,...

  • Quality Assurance

    4 weeks ago

    Kitchener, Canada Intellijoint Surgical Full time

    The Position   As part of the Quality Assurance and Regulatory Affairs (QA/RA) Team, the QA/RA Analyst plans and implements quality assurance and regulatory affairs activities required for timely completion and sale of Intellijoint Surgical medical devices in a regulated environment. As an integral member of the team, the QA/RA Analyst collaborates...

  • Quality Assurance

    4 weeks ago

    Kitchener, ON, Canada Intellijoint Surgical Inc Full time

    Quality Assurance & Regulatory Affairs Coordinator Contribute towards safe and effective products at a fast-growing medical technology company! Type of Position: Full Time (In-office presence required 3-days per week) Location: RRSP with employer match, health benefits (effective day-1!), wellness benefit, learning & development opportunities, paid...

  • Quality Assurance

    1 week ago

    Toronto, ON, Canada Ozmosis Research Inc. Full time

    I. JOB SUMMARYThe Quality Assurance & Regulatory Affairs Specialist (QARAS) provides support to the Senior Director of Quality Assurance & Regulatory Affairs (SDQARA) and Ozmosis team in quality control/quality assurance and regulatory affairs.II. QUALIFICATIONS• At minimum, completion of a Bachelor’s of Science degree or recognized equivalent•...

  • Quality Assurance

    1 week ago

    Toronto, ON, Canada Ozmosis Research Inc. Full time

    I. JOB SUMMARYThe Quality Assurance & Regulatory Affairs Specialist (QARAS) provides support to the Senior Director of Quality Assurance & Regulatory Affairs (SDQARA) and Ozmosis team in quality control/quality assurance and regulatory affairs.II. QUALIFICATIONS• At minimum, completion of a Bachelor’s of Science degree or recognized equivalent•...

  • Quality Assurance

    1 week ago

    Toronto, ON, Canada Ozmosis Research Inc. Full time

    I. JOB SUMMARY The Quality Assurance & Regulatory Affairs Specialist (QARAS) provides support to the Senior Director of Quality Assurance & Regulatory Affairs (SDQARA) and Ozmosis team in quality control/quality assurance and regulatory affairs. II. QUALIFICATIONS • At minimum, completion of a Bachelor’s of Science degree or recognized equivalent •...

  • Quality Assurance

    4 weeks ago

    Kitchener, Canada Intellijoint Surgical Full time

    **Tagline**: Contribute towards safe and effective products at a fast-growing medical technology company! **Type of Position**: Full Time (In-office presence required 3-days per week) **Location**: Kitchener, ON **Benefits**: RRSP with employer match, health benefits (effective day-1!), wellness benefit, learning & development opportunities, paid...

  • Associate Director, Quality Assurance and Regulatory Affairs

    2 weeks ago

    Toronto, ON, Canada Scientific Search Full time

    Associate Director – Quality Assurance & Regulatory Affairs Join a pivotal leadership role at a top-tier pharmaceutical company focused on pathbreaking scientific advancements. As an Associate Director of Quality Assurance & Regulatory Affairs, you will ensure compliance with Health Canada's stringent standards, maintaining the highest quality in the...

  • Associate Director Quality Assurance

    2 weeks ago

    Toronto, ON, Canada Scientific Search Full time

    Associate Director – Quality Assurance & Regulatory Affairs Location: Toronto, Ontario Summary: Join a pivotal leadership role at a top-tier pharmaceutical company focused on pathbreaking scientific advancements. As an Associate Director of Quality Assurance & Regulatory Affairs, you will ensure compliance with Health Canada's stringent standards,...

  • Quality Assurance and Regulatory Affairs specialist

    2 weeks ago

    Mississauga, ON, Canada Randstad Full time

    Our client in the food industry in Mississauga, ON is looking for a Regulatory and Quality Assurance Specialist to join their growing team. The Regulatory and Quality Assurance Specialist will report directly to the Quality Assurance Manager. Your role will involve ensuring compliance with industry regulations and upholding high product quality...

  • Regulatory Affairs Associate

    1 month ago

    Kitchener, Canada FluidAI Medical Full time

    **Job Title: Regulatory Affairs Associate** **Company Description**: FluidAI Medical is a medical device organization creating a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at their onset. Our clinically-validated platform sensing technology augments existing...

  • Regulatory Affairs Manager

    4 days ago

    Toronto, ON, Canada The People Co. Full time

    Our client, a leading food manufacturing company, is looking for a Regulatory Affairs Manager to manage, and drive the company’s regulatory department. This is a fantastic opportunity for someone who is looking to take their career in Regulatory Affairs to the next level, and be part of a company that truly invests in its employees.What we are looking...

  • Regulatory Affairs Manager

    3 days ago

    Toronto, ON, Canada The People Co. Full time

    Our client, a leading food manufacturing company, is looking for a Regulatory Affairs Manager to manage, and drive the company’s regulatory department. This is a fantastic opportunity for someone who is looking to take their career in Regulatory Affairs to the next level, and be part of a company that truly invests in its employees.What we are looking...

  • Regulatory Affairs Manager

    3 days ago

    Toronto, ON, Canada The People Co. Full time

    Our client, a leading food manufacturing company, is looking for a Regulatory Affairs Manager to manage, and drive the company’s regulatory department. This is a fantastic opportunity for someone who is looking to take their career in Regulatory Affairs to the next level, and be part of a company that truly invests in its employees.What we are looking...

  • Regulatory Affairs and Quality Specialist

    1 month ago

    Mississauga, ON, Canada Juno Pharmaceuticals Full time

    The Quality & Compliance Specialist jointly with the Manager, Quality is responsible for the quality assurance, quality control and quality compliance activities in support of the importation and distribution of JPC’s drug products. The candidate will support the Manager, Quality in leading the operational oversight, decision making and performance of...

  • Regulatory Affairs Specialist

    1 month ago

    Kitchener, Canada FluidAI Medical Full time

    **Job Title: Regulatory Affairs Specialist** **Company Description**: FluidAI Medical is a medical device organization creating a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at their onset. Our clinically validated platform sensing technology augments...

  • Regulatory Affairs Associate

    4 weeks ago

    Kitchener, Canada FluidAI Medical Full time

    **Company Description**: FluidAI Medical is a medical device organization creating a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at their onset. Our clinically-validated platform sensing technology augments existing wound drains and catheters, providing...

  • Quality Assurance Supervisor

    4 weeks ago

    Kitchener, ON, Canada Intellijoint Surgical Inc Full time

    Quality Assurance & Regulatory Affairs Coordinator Contribute towards safe and effective products at a fast-growing medical technology company! Full Time (In-office presence required 3-days per week) RRSP with employer match, health benefits (effective day-1!), Today, Intellijoint technology lives in the operating room, helping surgeons improve implant...

  • Regulatory Affairs Specialist

    3 days ago

    Etobicoke, ON, Canada Give and Go Prepared Foods Full time

    Give & Go Prepared Foods Corp. is a proud member of the Mondelēz family and has been a leading and growing North American manufacturer of baked goods for over 30 years. Its an exciting time to be part of the Give & Go team as we are growing rapidly and want you to become a part of our growth and extraordinarily bright future!Job Overview:As the Regulatory...