Regulatory Affairs and Quality Assurance Manager 

​​​Job Description

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Summary

Reporting to VP Engineering, the Regulatory Affairs and Quality Assurance Manager will be responsible for supporting the corporate wide Regulatory and Quality mandate for the worldwide sale and distribution of the Ventripoint Medical Devices.  Key responsibilities include assisting in: product release readiness, document/deliverable reviews; quality system effectiveness assessments; recommending process improvements and ensure compliance with the Ventripoint Quality Management System.

The position reports directly to the Vice President Engineering and Operations.

Internally, this person must work closely with Project Team Leaders, members of the project teams, and with other members of the QA department.  This person must promote positive and effective working relationships.  Externally, this person works with outside groups as required.

Key Accountabilities and Responsibilities

• Develop and maintain submissions to regulatory agencies required to allow Ventripoint products to be sold in all regions and markets. (FDA, CE, Health Canada)
• Develop and maintain the Ventripoint Quality Management System and supporting procedures capable of meeting ISO 9001:2015, ISO 13485, as well as FDA (QSR), European (CE Mark), and Health Canada (CAN-ISO 13485) requirements
• Manage auditing activities from the different regulatory agencies including FDA, Health Canada and other agencies.
• Manage QA and test staff and their activities to ensure adherence to producing a quality product and to conform to the Ventripoint Quality Management System.
• Monitor regulatory agencies for changes in policies and procedures and implement changes as required to maintain registrations.
• Maintain knowledge about applicable standards, directives and guidance’s necessary to facilitate notifications and submissions to regulatory agencies
• Develop quality system documentation (such as procedures and work instructions) to address new and updated standards and guidance’s, as required.
• Assist as required during clinical trials in accordance with rules mandated by regulatory agencies.
• Assist as required to develop project documentation (for example, risk plans) as required for inclusion in regulatory submissions
• Provide responses to regulatory agencies regarding product information or issues.
• Train staff in regulatory policies or procedures.
• Maintain current knowledge of relevant regulations, including proposed and final rules.
• Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.

 

Knowledge, Skills and Experience Required

Education:

• Formal post-secondary degree/diploma in regulatory affairs related to a Medical Device.
• Regulatory Affairs and Quality Assurance certifications an asset

 
Knowledge/Experience: 

• Experience working with the ISO 9001 quality standard is desirable.
• Working experience in a clinical environment is an asset.
• Training in quality assurance and auditing is desirable.
• Knowledge of quality and regulatory standards (ISO 9001, ISO 13485, FDA QSR, etc.) is an asset
• Experience with all aspects of the development lifecycle.

 
Skills: 

• Sound understanding of Quality Assurance methods.
• Proficient in the Microsoft family of products.
• Familiarity with defect tracking software packages.
• Must be willing to learn to possess knowledge and experience in medical applications.
• Excellent oral and written communication skills.

 
Attributes:

• Ability to work independently as well as participating in a team of professionals.
• Ability to respond to urgent situations appropriately by prioritization.
• Ability to leverage relationships across other departments and with external sources.
• Ability to follow-up with individuals without guidance.
• Accuracy and strong attention to detail is essential.

 

Disclaimer
 The above information on this job description has been designed to indicate the general nature and level of work performed by employees within this job.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.