Quality Assurance and Regulatory Affairs Assistant

2 months ago

Oshawa, Canada Pacific Surgical Holdings Ltd. Full time

**Job Title**: Quality Assurance and Regulatory Affairs Assistant

**Location**: Oshawa, ON

Pacific Surgical Holdings Ltd. is a family of dynamic healthcare companies focused on manufacturing, sales and service of medical devices operating from locations throughout North America. We are committed to bringing progressive products and service solutions to our customers in Canada and around the globe. Our company is dedicated to delivering high-quality products and services that meet regulatory standards and exceed customer expectations.

We are seeking a detail-oriented and motivated individual to join our team as a Quality Assurance and Regulatory Affairs Assistant. In this role, you will play a crucial part in ensuring that our products and services adhere to regulatory requirements and meet the highest quality standards. You will work closely with the Quality Assurance, Regulatory Affairs, Technical and Operational teams from multiple divisions across Pacific Surgical group of companies to support the maintenance of quality management systems (QMS) to ensure compliance with quality and regulatory standards such as ISO 9001, ISO 13485, Medical Device Regulations of Canada (SOR 98-282) and US (FDA CFR 820).

**Responsibilities**:

- Support with post-market surveillance activities in monitoring medical device recalls and alerts, measuring customer feedback and facilitating and reporting customer complaints
- Assist with the investigation, root cause analysis and reporting of non-conformities.
- Developing, implementing and measuring effectiveness of corrections, corrective actions and preventative actions working collaboratively with multi-disciplinary departments.
- Conduct document control activities, including preparing, reviewing, distribution, training, filling and archival of controlled documents.
- Support regulatory licence reviews to evaluate status of medical device licences and medical device establish licences.
- Support the review and updating of medical device listings with the US FDA.
- Participate in internal and external audits, including preparation, execution, and follow-up activities.
- Support supplier qualification activities to review and collect quality and regulatory information from suppliers.
- Participate and assist with the Occupational Health and Safety programs.
- Collaborate with cross-functional teams to address quality and regulatory issues and drive continuous improvement initiatives.
- Various tasks as specified by the QA/RA Managers.

**Qualifications**:

- Minimum one year experience in quality assurance and regulatory affairs required.
- Bachelor’s degree in a relevant field (e.g., Health Sciences, Public Health, Biomedical Engineering, or Regulatory Affairs).
- Some knowledge in ISO 9001, ISO 13485, MDSAP, ISO 14971, FDA CFR 820 or SOR 98-282 is preferred.
- Strong attention to detail and analytical skills.
- Strong written and verbal communication skills and efficient in communicating to inter-disciplinary and cross-functional team.
- Ability to accept responsibility and work independently while at the same time functioning as a strong team player.

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

Pay: $40,000.00-$48,000.00 per year

**Benefits**:

- Casual dress
- Commuter benefits
- Company events
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Profit sharing
- RRSP match
- Tuition reimbursement
- Vision care
- Wellness program

Flexible Language Requirement:

- French not required

Schedule:

- Day shift
- Monday to Friday

**Education**:

- Bachelor's Degree (preferred)

Work Location: In person

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