Quality Assurance and Regulatory Affairs Specialist - Jobs in Kitchener, ON

Job Description

*Tagline:*Ensure the delivery of safe, effective and innovative medical technology products*Type of Position: *Full time*Location: *Kitchener, ONThe 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 30,000 surgeries - helping us to gain real-world feedback from patients and surgeons to improve our products. We are seeking a Quality and Regulatory Affairs Specialist to join our headquarters in* Kitchener, ON* to ensure the delivery of safe, effective and innovative medical technology products.As a_ snapshot, _we are looking for someone who:

• Has experience working in a fast-paced environment with tight deadlines
• Has the aptitude to learn new software products easily
• Able to communicate effectively with internal, key employees
• Is very detail oriented and organized

The Position: The Quality Assurance and Regulatory Affairs Specialist will assist with the overall management of Intellijoint Surgical’s quality assurance and regulatory affairs strategy, and will act as a resource striving to meet all compliance requirements.Main Duties:

• Build and maintain a positive and productive relationship with internal and external contacts.
• Develop regulatory and document knowledge skills in order to provide effective services to internal customers.
• Coordinate and compile regulatory submissions, responses, and complaints to internal customers and external regulatory bodies.
• Responsible for labelling compliance and labelling requirements for each product suite.
• Responsible for completion of post-market surveillance activities: Quality Trends, Clinical Safety Reports, Post Market Surveillance Reports.
• Responsible for the scheduling and coordinating regulatory interactions and audits.
• With guidance and support, effectively prioritize, coordinate, and complete projects within established timeframes as assigned.
• Ensure electronic filing and coordination of submissions/documents/data is maintained and kept up-to-date.
• Assists in the maintenance, approval, and creation of quality documentation.
• Participation in cross functional teams for assigned projects.
• Supports quality assurance and operations initiatives and processes.

Skills and Experience to Enable Success:

• B.Sc. (life sciences or related disciplines strongly preferred) and/or 2-3 years of professional experience and related training
• Direct experience, working knowledge, or understanding of the regulatory and quality assurance environment as it relates to medical devices.
• Effective project management skills; attention to detail.
• Demonstrated strategic planning and problem-solving skills.
• Time management and multi-tasking skills.
• Effective interpersonal skills.
• Ability to consistently meet deadlines.
• Demonstrated ability to work in a cross-functional, multidisciplinary team environment.
• Knowledge of Microsoft Word, Excel, PowerPoint and the other Office Programs.
• Excellent written and verbal communication skills.

Expectations & Employee Experience:

• Be passionate about growth, personally and professionally and know that we will support you along the way.
• Work hard each and every day but know that you will be rewarded for that hard work.
• 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

ildQSamSdhJob Type: Full-timeQuick Apply

• Terms & Conditions
• New Privacy
• Privacy Center
• Accessibility

For Job Seekers

• Browse Jobs
• Advanced Job Search
• Emplois Quebec

For Employers

• Post a Job

Stay Connected