Manager Quality and Regulatory Affairs

2 weeks ago

Mississauga, Canada Profound Medical Full time

Our mission is to Profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic, problem-solvers focused on innovation, and looking to change the world. We are changing the paradigm for treating diseases such as prostate cancer by using real-time MR Imaging, thermal ultrasound and close-loop temperature feedback control, to gently ablate the diseased tissue with mínimal side effects.

If you share our values and want to work in a collaborative results focused culture and want to make a Profound impact in healthcare and your career, here is your chance.

**General Accountability**

The Manager, Quality and Regulatory Affairs is responsible for the implementation and maintenance of quality and regulatory strategies to meet requirements in regions where products are distributed.
Accountability includes the planning, preparation, maintenance and improvement of the Quality Management System and the applicable Regulatory Affairs activities.
This role is responsible for establishing and maintaining relationships with engineering, manufacturing, and other departments as needed, ensuring compliance with policies and procedures. Maintaining lifecycle management of distributed products. Providing guidance to the internal cross-functional teams to promote a culture of compliance.

**Duties and Responsibilities**
- The development, implementation, maintenance, continuous improvement, and effectiveness of its Quality Management System (QMS).
- Ensuring compliance with ISO13485, Medical Device Regulation EU 2017/745, FDA's Quality Systems Regulations, GMP's, Canadian Medical Device Regulations; and other international regulatory requirements where the product is distributed.
- Assist in fulfilling requirements of the Person Responsible for Regulatory Compliance under the EU MDR 2017/745.Assist in establishing department goals and implementing executable actions within the framework of the company objectives.
- Assist with regulatory strategy development and implementation of the strategic plans including investigational studies and regulatory approval plans for global commercialization.
- Working with key stakeholders to ensure timely execution of key deliverables including, but not limited to Pre-submission, IDE, IRB, annual reports, safety reports, country-specific regulatory submissions, etc..
- Provide managerial oversight and guidance to the team for quality and regulatory communications with internal and external stakeholders.
- Maintain Design History Files, Device Master, Regulatory Product Submissions, and approval records.
- Approve promotional materials for regulatory compliance.
- Review and or approve QMS procedures and processes.
- Ensure that all employees are familiar with, trained on, and follow all QMS procedures related to their jobs which can affect the quality of products.
- Evaluate changes to controlled documents for impact on submissions and filing requirements, including providing a technical review of and approval for proposed changes and supporting documentation.
- Review and or approve complaints including reportability assessment, CAPAs, and field correction and/or recall activities.
- Participate in 3rd party audit and inspection activities (ISO, Notified Body, FDA, Health Canada, etc.). Track and respond to audit items.
- Lead supplier management activities. Identify supplier quality issues and report to management in a timely manner.
- Assist with other duties, as assigned.

**Education**
- A minimum of a bachelor’s degree in science or engineering field. Advanced degree a plus.

**Certifications**
- Quality Assurance and Regulatory Affairs certification or equivalent experience

**Key Attributes (experience, skills and technical knowledge)**
- Minimum 5 years medical device experience; or equivalent combination of education and experience.
- Language Skills: Ability to read, analyze and interpret common business documents. Ability to respond to common inquiries or complaints from customers, members of the business community. Ability to write well. Ability to effectively present information to the top management.
- Experience with design and testing of electromechanical systems preferred.

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