Regulatory Affairs Officer

Sword Health is on a mission to free two billion people from pain as the world’s first and only end-to-end platform to predict, prevent and treat pain. 

With 67% of members achieving a pain-free life and a 70% reduction in surgery intent, at Sword, we are using technology to save millions for our 25,000 enterprise clients across three continents. Today, we hold the majority of industry patents, win 70% of competitive evaluations, and have raised more than $300 million from top venture firms like Founders Fund, Sapphire Ventures, General Catalyst, and Khosla Ventures.

Recognized as a Forbes Best Startup Employer in 2024, this award highlights our focus on being a destination for the best and brightest  talent. Not only have we experienced unprecedented growth since our market debut in 2020,  but we’ve also created a remarkable mission and value-driven environment that is loved by our growing team. With a recent valuation of $3 billion, we are in a phase of hyper growth and expansion, and we’re looking for individuals with passion, commitment, and energy to help us scale our impact. 

Joining Sword Health means committing to a set of core values, chief amongst them to “do it for the patients” every day, and to always “deliver more than expected” on behalf of our members and clients.

This is an opportunity for you to make a significant difference on a massive scale as you work alongside 900+ (and growing!) talented colleagues, spanning three continents. Your charge? To help us build a pain-free world, powered by technology, enhanced by people — accessible to all.

Sword Health is an AI care company addressing physical pain. Sword is committed to providing high-quality medical devices (SFW and HW) that improve patient outcomes and safety. As part of our ongoing commitment to excellence, we are seeking a talented and detail-oriented Medical Device Regulatory Affairs Officer to join our dynamic QARA team.

We are seeking a dedicated Regulatory Affairs Officer with at least 2-3 years of experience in the medical device industry with a good understanding of medical device regulations with focus on EU and US to join our QARA team. The successful candidate will be primarily responsible for maintaining and updating technical file documentation to ensure compliance with international regulations and standards, including digitalization initiatives. They will play a pivotal role in the change control process and will actively support  the QARA team by overseeing and coordinating project management activities. This role is critical in supporting Sword Health’s ongoing efforts to meet stringent regulatory requirements and to facilitate the successful marketing and distribution of our medical devices. 

Key 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.

Skills and expertise :

• 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.
• 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.
• 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. 

Total compensation range

€26,283 - €37,083 a year

Base: €17,955 - €28,215

Variable: €945 - €1,485

Net equity value per year: €7,383

These compensation bands are just the starting point. Once someone joins and proves they’re outlier talent, we adjust quickly to ensure their compensation aligns with their impact.

Our job titles may span more than one career level. Actual pay is determined by skills, qualifications, experience, location, market demand, and other factors. Compensation details listed in this posting reflect the base salary and any potential variable, bonus or sales incentives, and the Company’s estimation of the value of private company stock options, if applicable. The pay range is subject to change, future value of company stock options is not guaranteed, and compensation may be modified in the future. In addition to our total compensation, Sword offers a number of benefits as listed below.