Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the architectural Quality Management System (QMS) and regulatory remediation, integrating global procedures into cohesive, efficient workflows.

• Revise and amalgamate Standard Operating Procedures (SOPs) for the Design History File (DHF), Design and Development Files, Post-Market Surveillance (PMS), Labeling/UDI, EUDAMED, and global Regulatory Strategy to ensure compliance with FDA QMSR and ISO 13485 standards.

• Drive the cleanup of regulatory documentation and manage the Global Regulatory Submissions & Deficiencies Database.

• Guide global registration strategies and oversee submission execution across EU (MDR), UK (UKCA/SGS transition), Canada, APAC, and LATAM markets.

• Oversee interactions with Notified Bodies and EU Authorized Representatives for technical file evaluations, Notifications of Change (NoC), and Declaration of Conformity (DoC)/CE updates.

• Assist in regulatory assessment and intelligence mapping for the rollout of Eko Vet+ in various global regions.

• Act as the Regulatory Affairs (RA) representative on core project teams for hardware and AI/software launches.

• Standardize claims matrices, Instructions for Use (IFU) restrictions, and review processes for advertising/promotions across commercial and life sciences sectors.

• Assess and implement Regulatory Information Management Systems (RIMS) and AI-driven workflows.

• Ensure adherence to company policies and relevant laws.

• Carry out additional duties as assigned.

⛳️ Requirements

• Bachelor’s or Master’s/advanced degree in Engineering, Life Sciences, Regulatory Affairs, or a related technical field.

• 5–8+ years of progressively responsible regulatory affairs experience in medical devices, digital health, and/or Software as a Medical Device (SaMD).

• Extensive working knowledge of FDA 21 CFR 820 / QMSR, EU MDR 2017/745, ISO 13485, and global regulatory submissions.

• Direct experience in writing/submitting 510(k)s, Q-Subs, De Novo applications, Technical Files, and managing Notified Body reviews.

• Proven success in leading significant QMS remediation initiatives and global market entries.

• Excellent communication, organizational, and problem-solving abilities.

• Capability to perform essential job functions with or without reasonable accommodation.

• RAC (Regulatory Affairs Certification) is preferred.

• Experience in a startup or high-growth setting.

🏝️ Benefits

• The chance to contribute to products that enhance the health of millions.

• Generous paid time off.

• Stock incentive plans.

• Comprehensive Medical/Dental/Vision coverage, along with Disability and Life Insurance.

• One Medical membership.

• Parental Leave.

• 401k Matching.

• Learning and Development stipend.