SWORD Health is hiring a
Regulatory Affairs Officer in Portugal

Summary

Sword Health is a tech company focused on predicting, preventing, and treating pain with a mission to free two billion people from pain. They are seeking a Regulatory Affairs Officer with 2-3 years of experience in the medical device industry to join their team and maintain and update technical documentation for medical devices to ensure compliance with international regulations.

Requirements

• Previous experience (2-3 years) in the Medical Device industry or other regulated industry such as Pharma, IVD
• Bachelor’s degree in a technical, scientific, engineering or related field is preferred
• Good working knowledge of regulations and industry standards for US, CA and EU markets, such as ISO13485, EU MDR, 21 CFR 820, etc
• Proven experience in preparing and maintaining technical documents and technical files, including experience in Change Control
• Strong attention to detail and the ability to manage multiple projects under tight deadlines
• Excellent communication, interpersonal and organizational skills and proficiency in English
• Highly dynamic, motivated and proactive
• Team player with ability to successfully interact with representatives from a variety of disciplines within and external to Sword Health

Responsibilities

• Update and maintain technical documentation for medical devices in accordance with applicable regulatory requirements, including but not limited to the EU MDR, FDA guidelines, and other global regulatory frameworks
• Collaborate with cross-functional teams to gather necessary documentation and data
• Ensure all technical files are complete, current, and in compliance with relevant laws and standards
• Support the quality & regulatory department in audits and regulatory inspections
• Provide regulatory advice and guidance to project teams on regulatory requirements, especially related to changes in product design, labeling, or manufacturing processes
• Monitor regulatory developments within the medical device field and advise on impact and necessary actions

Preferred Qualifications

• Previous experience with NB submissions is an advantage
• Previous experience in supporting the Design Control process is an advantage

Benefits

• A stimulating, fast-paced environment with lots of room for creativity
• A bright future at a promising high-tech startup company
• Career development and growth, with a competitive salary
• The opportunity to work with a talented team and to add real value to an innovative solution with the potential to change the future of healthcare
• A stimulating environment with room for creativity
• A flexible environment where you can control your hours (remotely) with unlimited vacation
• Access to our health and well-being program (digital therapist sessions)
• Remote or Hybrid work policy