Regulatory Affairs Specialist – Medical Devices & SaMD

We are seeking a Regulatory Affairs Specialist to join a high-performing Medical Device Compliance team supporting innovative wearable technologies and Software as a Medical Device (SaMD) products. This role offers the opportunity to work on cutting-edge technologies, including augmented reality devices, wearable health technologies, and next-generation digital health solutions, supporting regulatory approvals across the US and international markets.

Key Responsibilities

• Support regulatory submissions and approvals for medical devices and SaMD products in the US, Canada, Europe, and other global markets.
• Prepare and manage regulatory documentation, including FDA submissions, technical files, and product change notifications.
• Collaborate with cross-functional teams including Engineering, Quality, Product Development, and international Regulatory Affairs teams to ensure compliance throughout the product lifecycle.
• Interact with regulatory authorities and support responses to regulatory inquiries and submission reviews.
• Develop and execute regulatory strategies to support product development, market access, and business objectives.
• Support ongoing compliance activities, including audits, site registrations, post-market surveillance, vigilance reporting, field actions, and product recalls where required.
• Provide regulatory guidance to project teams and stakeholders throughout the development and commercialization process.

Requirements

• Bachelor's degree in a scientific, engineering, or related discipline.
• 3+ years of experience within Regulatory Affairs in the medical device, digital health, or related regulated industry.
• Experience managing multiple projects simultaneously within a fast-paced, cross-functional environment.
• Strong understanding of global regulatory requirements and product lifecycle management.
• Ability to work independently while effectively collaborating with internal and external stakeholders.

Preferred Experience

• Knowledge of FDA regulations, EU MDR, Health Canada requirements, ISO 13485, ISO 14971, and other applicable global regulatory frameworks.
• Experience supporting Software as a Medical Device (SaMD), connected devices, wearable technologies, or digital health products.
• Advanced degree in a scientific, engineering, health sciences, or Regulatory Affairs discipline.
• RAC (Regulatory Affairs Certification) or equivalent professional certification.
• Strong technical writing, submission authoring, presentation, and stakeholder management skills.