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Quality and Regulatory Affairs Manager

2 weeks ago


St Jacobs, Canada Huron Technologies International INC Full time

Huron Digital Pathology is seeking a Quality and Regulatory Affairs Manager to oversee the maintenance, and ongoing evaluation of the Quality Management System (QMS), ensuring its continued effectiveness and suitability.

**Company Description**

**Job purpose**

The Quality and Regulatory Affairs Manager is responsible for overseeing the implementation, maintenance, and monitoring of the Quality Management System (QMS) for continued suitability and effectiveness.

It is the Quality and Regulatory Affairs Manger’s responsibility to ensure Huron Digital Pathology is adhering to _ISO13485 Medical devices — Quality management systems — Requirements for regulatory purposes and applicable regulatory requirements_.

The Quality and Regulatory Affairs Manager is appointed by Senior Management as the _**Management Representative**_ (ref: _ISO13485; 5.5.2_) with the responsibility and authority that includes:

- ensuring that processes needed for the quality management system are documented.
- reporting to top management on the effectiveness of the quality management system and any need for improvement.
- ensuring the promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organization.

The Quality and Regulatory Affairs Manager is appointed by Senior Management as the _**Person Responsible for Regulatory Compliance**_ (ref: _Regulation (EU) 2017/746; Article 15_) with the responsibility for ensuring that:

- conformity of the devices is appropriately checked, in accordance to the QMS under which the devices are manufactured, before a device is released;
- technical documentation of the EU declaration of conformity are drawn up and kept up to date;
- the post-market surveillance obligations are complied with in accordance with manufacturer obligations;
- the reporting obligations are fulfilled;
**Duties and responsibilities**
- Ensure processes are established, implemented, maintained, and improved in accordance with ISO 13485 and applicable regulatory standards
- Schedule and document actions from Quarterly Management and Scorecard reviews and provide assessment of the ‘health of the QMS’ as part of the management review process.
- Report to executive management on the performance of the quality management system
- Identify any areas that require improvement through analysis of corrective/preventive action results
- Act as liaison between Huron Digital Pathology and external QMS auditors
- Prepare and conduct internal audit of QMS as needed
- Develop, execute, and maintain the Internal Quality Audit Plan, to evaluate the complete QMS annually
- Monitor ISO 13485 and applicable regulatory requirements for any changes or upcoming changes in standards or requirements, twice monthly, and provide recommendations to HDP Management, as applicable.
- Ensure the promotion of awareness of customer and regulatory requirements throughout Huron Digital Pathology
- Assist in company personnel training related to the documented QMS policies and procedures
- Oversee the risk assessment activities and ensure that product and process changes have been reflected in risk assessment updates, if applicable.

**Qualifications**
- Working knowledge of ISO 13485 and applicable regulatory standards
- Ability to analyze and interpret standards, technical procedures and governmental guidance and regulation documents
- Excellent verbal and written communication skills
- Effective problem-solving skills, demonstrated project management skills and experience
- Proficiency in Microsoft Office (Word, Excel) and SharePoint.

**Job Types**: Full-time, Permanent

Additional pay:

- Bonus pay

**Benefits**:

- Casual dress
- Company events
- Dental care
- Flexible schedule
- Life insurance
- On-site parking
- Paid time off
- Vision care

Schedule:

- Monday to Friday

Work Location: In person