Regulatory Affairs Consultant
$156,000–$312,000 year
RemoteUnited States or Canada
Job Summary
Lead and support regulatory strategy for medical devices and device-constituent combination products across US, CA, and EU markets. Prepare, review, and manage submissions including ITAs, IDEs, and CTAs while providing guidance on electromechanical devices with embedded or connected software. Interpret evolving requirements such as MDR, MDSAP, FDA, and Health Canada to ensure compliance throughout the product lifecycle. Collaborate cross-functionally with R&D, quality, and clinical teams to identify risks and recommend mitigation strategies for timely market access. Maintain up-to-date knowledge of global regulatory trends. This role requires 8+ years of experience and is available as a W2 or 1099 contractor for 12 months at $75-$150 hourly.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or related discipline
- 8+ years of regulatory affairs experience within the medical device, pharmaceutical, or biotechnology industry
- Proven experience in global regulatory affairs for medical devices or device-constituent combination products
- Regulatory experience in US, Canada (CA), and EU
- Demonstrated expertise with electromechanical devices, including systems with intermediate to advanced software components
- Direct experience preparing and/or managing investigational device filings (e.g., ITA, IDE, CTA)
- Strong understanding of applicable regulatory frameworks (e.g., Health Canada regulations, EU MDR, FDA 21 CFR)
- Excellent communication skills, with the ability to translate complex regulatory requirements for cross-functional stakeholders
Desired Qualifications
- Advanced degree
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