Regulatory Affairs Specialist

7 days ago

London, Canada Deep Breathe Full time

As a growing team, we value individuals who see challenges as an opportunity for growth and take true ownership of their work. This role offers significant future growth opportunities, such as building and leading a regulatory team, as well as broadening leadership capabilities within the company.

**Educational Background**:

- Bachelor’s and/or Masters in Engineering or Science and/or Graduate Certificate or Diploma in Regulatory Affairs
- Additional applicable certifications are considered an asset but not required (i.e., RAC, Canadian Association of Professionals in Regulatory Affairs, AMWA)

**Examples of previous work/technical writing portfolio are encouraged, but not required**

**Role Responsibilities/Requirements**:

- Prepare regulatory submissions (510k, De Novo, etc.) for FDA, Health Canada, CE Mark, and other relevant bodies.
- Research proper product codes, submission types, and predicates for potential products, influencing design decisions.
- Liaise with consultants, regulatory agencies, and external entities, as well as manage third-party audits and regulatory inspections to ensure compliance with industry standards and timely approvals.
- Prepare and organize regulatory submission packages, drafting the necessary documentation (e.g., indications for use, device descriptions, software documentation, and labeling) in collaboration with technical leads
- Develop, implement, and maintain a comprehensive quality system compliant with FDA, ISO 13485, Health Canada (MDSAP), and other relevant regulations.

**May help provide additional support in the following areas**:

- Develop and maintain a post-market compliance workflow and knowledge base for the company, with the potential to lead the development of our post-regulatory plan.

**Not required, but preferred**:

- Experience in ML/AI
- Experience in ultrasound/imaging

Pay: $83,000.00-$100,000.00 per year

**Benefits**:

- Company events
- Dental care
- Extended health care
- On-site parking
- Paid time off
- Work from home

Schedule:

- Monday to Friday

Application question(s):

- Are you able to work in a hybrid capacity from either London, Ontario (preferred) or Toronto, Ontario?

**Education**:

- Bachelor's Degree (required)

**Experience**:

- Regulatory Submission: 1 year (preferred)

Work Location: Hybrid remote in London, ON N6G 4X8

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