Regulatory Affairs Specialist

2 weeks ago

Kitchener, Canada FluidAI Medical Full time

**Job Title: Regulatory Affairs Specialist**

**Company Description**:
FluidAI Medical is a medical device organization creating a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at their onset. Our clinically validated platform sensing technology augments existing wound drains and catheters, providing healthcare providers with a smart monitoring tool that can support earlier detection of deadly complications and enhance the delivery of care. We are an equal opportunity employer and have a diverse team representation across language, ethnicity, gender, and nationality.

**Why join FluidAI?**
- Mission to save lives and improve patient care with technology that is already deployed on patients in real-world settings.
- Work with a high-performing and cross-functional team that is empowered to grow, learn, and contribute across all levels of the organization.
- Direct access to world-class regulatory consultants to enable you in your role and develop expertise.
- Personal career-focused development and training with access to workshops, coursework, and experienced mentors/consultants.
- Health and wellbeing benefits, including vision, drugs, dental, and life insurance.
- Regular offsite activities - past events include rafting, axe-throwing, sports leagues, and the usual BBQ.
- WFH/WFO flexible hybrid model.
- Unlimited vacation and paid parental leave.

**Job Summary**:
We are looking for someone self-driven and able to adapt in a rapidly growing organization, someone who loves to learn and can quickly tackle new challenges as they arise.

You will work with a high performing cross-functional team interfacing with product development, manufacturing, and quality assurance functions at various stages, including product development, product realization, and post-market surveillance.

It's not everyday that you get a chance to make a direct impact on people's health. If you're looking to join a strong team advancing a meaningful product, this is for you

**Responsibilities**:

- Support in compiling and writing documentation for regulatory submissions and technical files in a timely manner.
- Provide regulatory input to product development personnel throughout product lifecycle.
- Anticipate and identify risks associated with regulations related to product development and participate in the evaluation/mitigation of identified risks.
- Develop/improve processes pertaining to regulatory data collection/reporting and maintenance of annual licenses, registrations, and product listings.
- Support in the submission of notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information.
- Assist in managing post-market product registrations, complaint handling, recall reporting, etc. to ensure ongoing compliance with current government and industry regulations.
- Review regulatory submissions and dossiers for accuracy and compliance.
- Compile supporting documentation and prepare appropriate responses to inquiries and citations from regulatory bodies within the required timelines.
- Support in ensuring advertising and promotion for new or revised products is compliant with relevant regulations throughout the product development process and lifecycle, including coordination of required translations for various markets.

**Qualifications**:

- Bachelor’s Degree (BSc, BASc, BA) in Biomedical Sciences, Biology, Health Sciences, Biomedical Engineering, Public Health, or related discipline.
- Working understanding of the regulatory culture and mindset.
- Ability to interpret and navigate regulations, regulatory guidelines, and legal-style documents.
- 4-6 years of relevant experience within the MedTech, biotechnology, biopharmaceutical industry, or within a health authority with exposure to complete device/product lifecycle.
- 1+ year(s) of experience preparing & filing regulatory submissions with Health Canada, USFDA, and/or under EU MDR, preferably for medium-risk and/or novel devices.
- Excellent professional writing skills.
- Passion for documentation and detail.
- High level of integrity and ethical conduct.
- Strong interpersonal skills.
- Excellent team player.
- Ability to prioritize workload to ensure all deadlines are met.
- Ability to work independently with mínimal supervision.
- Comprehensive knowledge of common software programs/tools.

**Bonus Qualifications**:

- Post-graduate degree (e.g., MS) or certificate in Public Health or Regulatory Affairs.
- Working knowledge of the regulatory review process with the USFDA, including understanding of USFDA’s thinking, preferably for novel technology such as the De Novo pathway and required validation approach.
- Understanding of quality management system (QMS) structure, requirements, and relevant best practices (GxP).
- Basic knowledge of product development processes.
- Basic knowledge of internal and external aud

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