Compliance Specialist

2 weeks ago

Barrie, Canada Southmedic Inc. Full time

**REPORTS TO**: Quality Assurance & Compliance Manager

**JOB SUMMARY**

The Compliance Specialist is responsible for supporting the maintenance and overall health of the Southmedic Quality Management System by providing compliance support to Engineering, Document Control and Regulatory Affairs. The Compliance Specialist will also support in the execution of regulatory activities to support Southmedic’s proprietary medical devices.

**KEY DUTIES**
- Involved in all regulatory activities associated with the Tier1 Proprietary Products, to ensure compliance with the regulatory requirements of Canada (Health Canada), US (FDA), Europe (MDD), and other international opportunities.
- Support and champion the Quality Policy Manual (QPM) and the Quality Management System (QMS) through the maintenance and establishment of electronically controlled documents through the uniPoint software.
- Identify areas of opportunities within the Quality Management System (QMS) to support Southmedic’s key business objectives through the initiation of Corrective and Preventive Actions when appropriate.
- Take ownership of projects and work independently within a team environment to reach departmental and company goals.
- Communicate clearly, effectively, and professionally with customers, registrars, regulatory representatives, suppliers and within the Southmedic team.
- Lead internal audit program
- Manage Restricted Substances program.
- Key support to External, Customer and Regulatory audits.
- Conduct and schedule supplier audits.
- All other projects and duties as assigned.

**EDUCATION/EXPERIENCE/SKILLS**
- Bachelor of Science or Engineering, or post-graduate education in a Quality Assurance or Regulatory discipline
- Experience working within a Quality Management System including ISO 9001, ISO 13485, and within a regulated manufacturing environment
- Experience in regulatory affairs, customer service, root cause analysis, meeting management, time management, and technical writing
- Strong background in GMPs, EU MDD/MDR, MDSAP and FDA Part 820 requirements would be considered an asset.
- Experience or training in auditing, would be considered an asset.

Southmedic is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation for disability during any stage of the recruitment process, please advise the Human Resources Department.

SM

  • Accounts Payable Specialist

    3 days ago

    Barrie, Canada Environmental 360 Solutions Full time

    **Company Overview** Founded in 2018, Environmental 360 Solutions (E360S) is dedicated to becoming one of North America's leading and most trusted environmental management companies. Growing through acquisition and organically, E360S provides environmental and waste management solutions to municipalities, commercial and residential customers. **Position...

  • Quality Assurance Specialist

    5 days ago

    Barrie, Canada Southmedic Inc. Full time

    The Quality Specialist will champion corrective and preventative action teams for customer, supplier and internal non conformances. The Quality Specialist will provide Quality Engineering support for both proprietary products and contract manufacturing. The Quality Specialist will participate in risk mitigation activities and will analyze quality trends for...

  • IT Specialist

    2 weeks ago

    Barrie, Canada 100 Reasons Y Full time

    Posted Wednesday, March 20, 2024 at 4:00 a.m. | Expires Saturday, March 30, 2024 at 3:59 a.m. The opportunity: Reporting to the IT Manager, the IT Specialist acts as the first point of contact for any IT-related issues, will support the IT team by monitoring and responding to internal requests, troubleshooting technical issues for existing systems, and...

  • IT Specialist

    2 weeks ago

    Barrie, Canada 100 Reasons Y Full time

    Posted Wednesday, March 20, 2024 at 4:00 a.m. | Expires Saturday, March 30, 2024 at 3:59 a.m. The opportunity: Reporting to the IT Manager, the IT Specialist acts as the first point of contact for any IT-related issues, will support the IT team by monitoring and responding to internal requests, troubleshooting technical issues for existing systems, and...

  • IT Specialist

    1 week ago

    Barrie, Canada 100 Reasons Y Full time

    Posted Wednesday, March 20, 2024 at 4:00 a.m. | Expires Saturday, March 30, 2024 at 3:59 a.m. The opportunity: Reporting to the IT Manager, the IT Specialist acts as the first point of contact for any IT-related issues, will support the IT team by monitoring and responding to internal requests, troubleshooting technical issues for existing systems, and...

  • Compensation and Job Evaluation Specialist

    Found in: Talent CA C2 - 2 weeks ago

    Barrie, Canada City of Barrie Full time

    Choose Barrie The City of Barrie is a vibrant, progressive, and growing community with deep connections to our heritage, to nature and to the opportunities surrounding us. Our community values quality of life; the ability to play year-round with 300 hectares of park space, our beautiful waterfront, our lively downtown core and the nearby hills,...

  • IT Specialist

    Found in: Talent CA C2 - 3 weeks ago

    Barrie, Canada YMCA of Simcoe-Muskok Full time

    The opportunity: Reporting to the IT Manager, the IT Specialist acts as the first point of contact for any IT-related issues, will support the IT team by monitoring and responding to internal requests, troubleshooting technical issues for existing systems, and setting up equipment across our locations. This role will be a key contributor for the...

  • IT Specialist

    Found in: Jooble CA O C2 - 2 weeks ago

    Barrie, ON, Canada 100 Reasons Y Full time

    Posted Wednesday, March 20, 2024 at 4:00 a.m. | Expires Saturday, March 30, 2024 at 3:59 a.m. The opportunity: Reporting to the IT Manager, the IT Specialist acts as the first point of contact for any IT-related issues, will support the IT team by monitoring and responding to internal requests, troubleshooting technical issues for existing systems, and...

  • Scotiamcleod Branch Administrator

    1 week ago

    Barrie, Canada Scotiabank Full time

    Requisition ID: 174942 As a cornerstone business within Scotia Wealth Management®, ScotiaMcLeod has earned a reputation for integrity based on service excellence and trusted investment advice. Our advisors and teams pride themselves on exploring innovative approaches to protecting and growing their clients' assets. When you join ScotiaMcLeod, you’ll be...

  • Business Development Specialist

    Found in: Talent CA C2 - 4 days ago

    Barrie, Canada NAPA Auto Parts Full time

    Job DescriptionReporting to the NAPA AUTOPRO Regional Director, this position has three main areas of focus:  Support the active members by developing the business of the banner. Increase their use of the services offered and improve their compliance with the program's membership standards; Generate sales growth among banner members and increase the...

  • Business Development Specialist

    Found in: Talent CA C2 - 2 weeks ago

    Barrie, Canada NAPA Auto Parts Full time

    Job DescriptionReporting to the NAPA AUTOPRO Regional Director, this position has three main areas of focus:  Support the active members by developing the business of the banner. Increase their use of the services offered and improve their compliance with the program's membership standards; Generate sales growth among banner members and increase the...

  • Engineering Manager

    1 week ago

    Barrie, Canada Acara Solutions Full time

    Engineering Manager Lead and manage the design and analysis of our company's product, including patient ceiling lifts, patient mobile lifts, and specification of various types of mechanical equipment. Responsibilities: Develop and review mechanical engineering calculations, drawings, specifications, and reports, ensuring compliance with applicable codes,...

  • Superintendent of Program Services

    4 days ago

    Barrie, Canada Simcoe Muskoka Catholic District School Board Full time

    With 51 schools, over 24,000 students and more than 4,000 employees, the Simcoe Muskoka Catholic District School Board (SMCDSB) is a Catholic education community bound together by our beliefs. Our facilities are located in some of the most beautiful natural settings in the province. Our Board encompasses a large and dynamic mixture of urban centers, small...

  • Quality Technician

    Found in: Jooble CA O C2 - 16 hours ago

    Barrie, ON, Canada Manpower Full time

    We are seeking a Quality Assurance Specialist to fulfill a 4-month contract, and partner their skills with a global cannabinoid company, committed to advancing cannabis research, technology and product development. Working at the Stayner ON manufacturing facility, this position supports monitoring of process control methods and parameters, batch record...

  • Engineering Manager

    Found in: Jooble CA O C2 - 2 weeks ago

    Barrie, ON, Canada Acara Solutions Full time

    Engineering Manager Lead and manage the design and analysis of our company's product, including patient ceiling lifts, patient mobile lifts, and specification of various types of mechanical equipment. Responsibilities: Develop and review mechanical engineering calculations, drawings, specifications, and reports, ensuring compliance with applicable...