Regulatory Affairs and Quality Assurance Specialist

1 day ago

Mississauga, Canada Neuro Spinal Innovation Inc. Full time

The Regulatory Affairs and Quality Assurance department is seeking an urgent hire for a **Regulatory Affairs and Quality Assurance Specialist** to provide support to register company products worldwide with a primary focus on the North American markets: FDA and Health Canada medical devices submissions.

Furthermore, the Regulatory Affairs and Quality Assurance Specialist will lead the Quality Assurance with a focus to maintain the company's quality management system.

Liaising with the internal team on all regulatory affairs and quality assurance matters related to product development and registrations.

**Responsibilities**:

- Assist with regulatory assessments to support new product development;
- Create and review product and manufacturing documentation and changes to ensure compliance with applicable regulations;
- Stay vigilant to domestic and global regulatory trends, laws and changes utilizing regulatory intelligence tools;
- Maintain positive and cooperative communications and collaboration with all internal and external stakeholders;
- Other duties as required and as training and experience allows;
- Ensure ISO compliance across the organization;
- Assist operations and local quality functions in tracking, documenting, and reporting quality levels;
- Manage QMS by keeping all databases on track with all NCRs, CAPAs, CRs, suppliers listings, Unit tracking, and others;
- Keep all internal quality and SOPs up to date as per new or revised regulatory requirements;
- Lead audits to maintain company QMS (MDSAP) and compliance under MDD/MDR.

**Core Competencies**:

- Knowledge and experience in regulatory affairs principles, processes, and industry standards for medical devices;
- Knowledge of recognized standards for medical devices, products, testing, QMS, MDSAP, ISO 13485, IEC, and others;
- QMS audits;
- Ability to work well within a team and as an individual contributor;
- Excellent organizational and interpersonal skills;
- Working knowledge of MS Office;
**Job Requirements**:

- At least 3 years of experience in the industry for medical devices and for software as a medical device;
- Excellent understanding of FDA and Canadian medical devices regulations;
- International regulatory experience in addition to North American regulatory experience is an asset;
- Proven experience in internal or government inspections and audits (an asset).

 **Qualifications**:

- Bachelor's Degree in life sciences or Biomedical engineering or equivalent;
- Regulatory Affairs Certificate or Post-Graduate Diploma in Regulatory Affairs is an asset;

Pay: $20.00 per hour

Schedule:

- 8 hour shift

Ability to commute/relocate:

- Mississauga, ON: reliably commute or plan to relocate before starting work (required)

**Education**:

- Bachelor's Degree (preferred)

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