Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist - Class III Endovascular Devices

Location: Calgary, AB
Type: Full-Time
Company: Fluid Biomed Inc.

**About Fluid Biomed**:
Fluid Biomed is a pioneering medical device startup developing the world’s first bioabsorbable stent designed to treat brain aneurysms and transform neurovascular care.

As we progress toward key clinical and regulatory milestones, we are seeking a Regulatory Affairs Specialist to join our dynamic technical team. This full-time role offers the opportunity to contribute directly to the development and commercialization of a breakthrough neurovascular device, with a focus on FDA submissions and regulatory strategy for Class III endovascular products.

Position Summary

As a Regulatory Affairs Specialist at Fluid Biomed, you will be responsible for driving the preparation and execution of US FDA regulatory filings—including IDE, pre-submission, pivotal clinical trial submissions, and PMA—for our Class III bioabsorbable stent. You will serve as a critical team member ensuring regulatory strategy and execution align with business and clinical objectives. This is a hands-on, cross-functional role with high visibility and impact.

Key Responsibilities

Regulatory Strategy & Submissions
- Develop regulatory strategies that align with US regulatory requirements and business milestones.
- Ensure submissions are scientifically sound, regulatory-compliant, and address Class III implantable device requirements.

FDA and Agency Interactions
- Serve as the point of contact with the FDA for regulatory communications, including Q-Sub meetings, feedback responses, and deficiency resolution.
- Prepare and coordinate responses to FDA questions and requests within defined timelines.

Cross-Functional Collaboration
- Work closely with R&D, clinical, preclinical, and quality teams to compile technical and clinical documentation needed for regulatory submissions.
- Review design and development changes for regulatory impact and provide guidance on required documentation and approvals.

Documentation & Compliance
- Maintain up-to-date records of all FDA communications and submissions.
- Support the development and maintenance of regulatory SOPs and work instructions related to submission processes and regulatory compliance.
- Assist in regulatory audits, including preparation, hosting, and follow-up.

Clinical Support
- Provide regulatory input into clinical trial design to ensure FDA and global compliance.
- Assist in the development of clinical trial protocols, informed consent forms (ICFs), and trial registration submissions.
- Ensure regulatory alignment for labeling and packaging of clinical and commercial devices.

**Qualifications**:
Required
- Bachelor’s degree in Life Sciences or related field.
- Minimum 5 years of experience in Regulatory Affairs for medical devices.
- Direct experience preparing and submitting FDA regulatory filings (Pre-Sub, IDE, PMA) for Class III implantable devices.
- Mandatory experience with endovascular devices (e.g., stents, catheters, delivery systems).
- Strong understanding of FDA regulations (21 CFR Parts 50, 56, 812, 814), ICH-GCP, ISO 13485, and ISO 14155.

Preferred
- Experience in the neurovascular device sector or in neurology/cardiology-adjacent regulatory work.
- Familiarity with US and international regulatory systems including Health Canada and EU MDR.
- Experience supporting early feasibility studies and pivotal trials in the US.

Key Attributes
- Strategic thinker with strong attention to detail.
- Exceptional written and verbal communication skills.
- Highly organized and comfortable working in a fast-paced, startup environment.
- Proactive, collaborative, and flexible.

Pay: $60,849.90-$107,322.14 per year

**Benefits**:

- Extended health care
- Life insurance
- On-site parking
- Paid time off

Work Location: In person