QA/ra Manager

3 months ago

Waterloo, Canada KA Imaging Full time

KA Imaging has innovated a novel color X-ray detector that can visualize bone and soft tissue separately. We have several issued patents that protect the technology and our product pipeline includes a CAT scan replacement product which enables better visualization than traditional X-rays. We are 510k and Health Canada cleared. We are looking for an individual that is energetic, self-driven and can drive the teams to provide necessary information required for regulatory submissions.

**Overview**

The RA/QA Manager will be responsible for assuring the implementation of regulatory affairs and quality assurance systems and procedures relating to ISO 13485, MDSAP, FDA, Health Canada, European Union MDR and other regulations as required. The RA/QA Manager will be the Management Representative and is responsible for ensuring compliance with medical device regulations in Canada, US, EU and other jurisdictions where KA Imaging medical devices are distributed.

**Responsibilities**
- Create the quality manual and ensuring the quality manual and related procedures are up to date and compliant
- Create and ensure all procedures and practices meet regulatory requirements
- Create and/or revise the quality system procedures and work instructions
- Manage engineering change orders using PLM system
- Scheduling
- Prepare presentations to provide project updates or issues needing resolution
- Coordinate with other groups (Engineering, Supply Chain, Quality, Manufacturing, etc.) to ensure accurate, complete, and efficient updates to the procedures
- Create project plans and act as project manager to implement plans in QA and RA
- Prepare regulatory submissions and related maintenance documentation (amendments, supplements, annual reports, Device History File, Device Master Record, etc.) for Regulatory Health Authorities within defined time schedule.
- Manage site compliance documents such as GMP certifications and site registration documents.
- Determines regulatory strategy and filing strategy for manufacturing, facility changes and R&D activities
- Acts as regulatory liaisons and single point of contact in meetings and interact with members other project team and sub-teams;
- Review all changes (change control) to manufacturing processes and laboratory methods and specifications to ensure compliance with regulatory guidelines and to maintain adequate control and flexibility for the life cycle management of the product.
- Supervise the work of the Regulatory Affairs & Quality System Specialist
- Other duties as assigned

**Qualifications**
- B.S./M.S. in Engineering or Sciences (mechanical, electrical, industrial, software, computer, biology, physics, chemistry, etc.)
- In-depth understanding of good documentation practices
- Strong working knowledge of writing, editing, proofreading, English spelling, grammar, and punctuation
- Must be able to work independently with mínimal supervision Strong independent judgment and decision-making abilities required. Strong knowledge of relevant regulatory guidance.

**Benefits**:

- Company events
- Dental care
- Extended health care
- Flexible schedule
- Stock options
- Vision care

Schedule:

- Monday to Friday

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- medical device regulations in Canada, US, EU: 3 years (preferred)
- implementation of RA and QA systems and procedures: 3 years (preferred)

Work Location: Hybrid remote in Waterloo, ON

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