Remotehey

The Regulatory Affairs Specialist is responsible for preparing, submitting, and maintaining regulatory documentation to support global approvals of high-risk or implantable medical devices. This role ensures compliance with U.S. FDA regulations, EU MDR 2017/745, and other international requirements, supporting product lifecycle management from development through post-market surveillance.

Department: Regulatory Affairs

Reports To: Senior Regulatory Affairs Manager

Key Responsibilities

• Prepare and submit regulatory documents such as IDEs, PMAs, PMA Supplements, Technical Documentation (per EU MDR), and global registrations (e.g., Canada, Japan, China, Australia).
• Ensure labeling, Instructions for Use (IFUs), and promotional materials meet regulatory requirements for Class III devices.
• Lead or support regulatory strategy development for new product introductions, design changes, and sustaining products.
• Maintain compliance with regulatory standards including FDA 21 CFR Parts 807, 812, 814, and EU MDR Annexes I–III, IX, X.
• Support the maintenance of Clinical Evaluation Reports (CERs), Risk Management documentation (ISO 14971), and Post-Market Surveillance (PMS) activities.
• Collaborate with cross-functional teams (R&D, Clinical, Quality, Marketing) to ensure regulatory requirements are met throughout the product lifecycle.
• Participate in internal audits, FDA inspections, and Notified Body assessments as the Regulatory SME.
• Monitor and communicate changes in global regulations and assess the impact on existing products and documentation.
• Maintain regulatory records, files, and tracking systems in accordance with company procedures and quality systems (ISO 13485, QSR).
  
  

Skills and requirements

Qualifications

Required:

• Bachelor’s degree in Regulatory Affairs, Biology, Pharmaceutical, Life Sciences, or related field.
• 2+ years of regulatory affairs experience in the medical device industry, with at least 2 years supporting Class III devices.
• Strong working knowledge of U.S. FDA regulatory pathways (e.g., PMA, IDE) and EU MDR Technical Documentation requirements.
• Experience preparing regulatory submissions and responding to regulatory authority queries.
• Familiarity with ISO 13485, ISO 14971, and applicable international regulations (e.g., TGA, PMDA, NMPA).
• Strong project management, organizational, and communication skills.
  
  

Preferred

• Experience with implantable devices.
• Experience with software used in documentation and submission preparation (e.g., regulatory databases).
  
  

Personality

• Independent: You are independent in organizing your daily tasks, able to manage your work in a remote setting.
• Detail-oriented and organized: Your work is highly organized and precise, with a keen attention to detail and a structured approach to every task to ensure compliance.
• Resilient and adaptable: You bring a resilient, can-do attitude and demonstrate persistence when facing challenges.
• Collaborative: You have strong interpersonal and communication skills to effectively collaborate with internal teams and external stakeholders