Regulatory Affairs Officer

Summary

Join Sword Health, a leading AI care company, as a Medical Device Regulatory Affairs Officer and contribute to our mission of freeing billions from pain. You will play a pivotal role in maintaining and updating technical file documentation, ensuring compliance with international regulations. Collaborate with cross-functional teams, manage projects, and provide regulatory guidance. This position requires 2-3 years of experience in the medical device industry and a strong understanding of EU and US regulations. Based in Portugal, this role offers competitive benefits including health insurance, remote work options, flexible hours, and unlimited vacation.

Requirements

• Previous experience (2-3 years), in the Medical Device industry (or other regulated industry such as Pharma, IVD)
• 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
• Possess a valid EU visa and be based in Portugal

Responsibilities

• Update and maintain technical documentation for medical devices in accordance with applicable regulatory requirements, including but not limited to the EU MDR (Medical Device Regulation), FDA guidelines, FDA CFR and other global regulatory frameworks
• Collaborate with cross-functional teams, including R&D, Quality Assurance, and Clinical Affairs, to gather necessary documentation and data
• Ensure all technical files are complete, current, and in compliance with relevant laws and standards and support the digitalization activities
• Assist the team leadership in overseeing and coordinating QARA project management activities
• Support the quality & regulatory department (QARA), 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

• Bachelor’s degree in a technical, scientific, engineering or related field is preferred
• Previous project management experience is an advantage
• Previous experience with NB submissions is an advantage
• Previous experience in supporting the Design Control process is an advantage

Benefits

• Health, dental and vision insurance
• Meal allowance
• Equity shares
• Remote work allowance
• Flexible working hours
• Work from home
• Unlimited vacation
• Snacks and beverages
• English class
• Unlimited access to our Learning Platform