Manager - Regulatory Affairs and Quality Assurance

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**
- Ensure ongoing ISO 13485 and MDSAP certification through maintenance of the Quality Manual, Quality Policy and Procedures.
- Ensuring all procedures and practices comply with regulatory requirements.
- Scheduling, preparing presentations to provide project updates or issues needing resolution
- Coordinating with other groups (Engineering, Supply Chain, Quality, Manufacturing, etc.) to ensure processes and documentation comply with requirements.
- Create project plans and act as project manager to implement plans in QA and RA
- Prepare regulatory submissions to support product registrations in defined markets
- Maintain technical documentation in support of Regulatory requirements and complete annual reports and Post Market Surveillance activities, including Clinical Evaluation Reports, and Post-Market Clinical Follow-up.
- Ensure labelling and instructions for use meet Regulatory requirements
- Determine regulatory strategy and filing strategy for manufacturing, facility changes and R&D activities
- Participate in and monitor Change Review process to ensure compliance with regulatory requirements
- Manage and maintain Training records, including development of initial employee training plans.
- Evaluate potential complaints for impact and reportability and ensure that investigations are completed in accordance with documented procedures
- Assess product non-conformances, and process deviations for risk and ensure appropriate actions are taken
- Manage corrective and preventative action process to ensure effective analysis and implementation
- Complete supplier evaluations and manage supplier corrective action process
- Act as key contact and facilitator for internal and external Regulatory audits
- Participate in system and process validation activities and ensure ongoing Regulatory compliance
- Support reviews of Distribution and Quality Agreements
- Provide support and guidance to Engineering regarding applicable Safety, EMC, Risk and other standards adopted by Regulatory authorities
- Stay up to date with changes in Regulatory requirements and advise impacted teams
- Monthly Quality reporting and trend analysis
- Coordinate and facilitate activities related to QMS Management Review
- Other duties as assigned

**Qualifications**
- B.S./M.S. in Engineering or Sciences (mechanical, electrical, industrial, software, computer, biology, physics, chemistry, etc.)
- Experience with ISO 13485, MDSAP, and CE marking
- Strong knowledge of Regulatory requirements related to FDA CFR parts 11 and 820, Health Canada SOR/ 98-282 and EU MDR 2017/745
- Knowledge of standards applicable to Medical devices such as IEC 60601 series, IEC 62304, and ISO 14971
- In-depth understanding of good documentation practices and continuous improvement methodologies
- Strong skills related to writing, editing, proofreading, English spelling, grammar, and punctuation
- Able to communicate effectively within cross functional teams and with external auditors and customers
- Must be able to work independently with mínimal supervision and have strong independent judgment and decision-making abilities.

**Benefits**:

- Company events
- Dental care
- Extended health care
- Flexible schedule
- Paid time off
- 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)
- Regulatory Audits: 3 years (preferred)

Work Location: Hybrid remote in Waterloo, ON

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