Quality and Regulatory Specialist

Position Quality and Regulatory Affairs Specialist Company Description FormlyAI is changing the way the world achieves medical device compliance. Our team delivers quality and regulatory services to clients leveraging our expert team and intelligent, trusted AI solutions to ensure our clients get their life-saving technology to market and through regulatory certification faster than ever before. We are on the forefront of AI development and are a team of industry experts, founders, and trailblazers. At FormlyAI our mission is medical device compliance made easy, for everyone. The Opportunity This is a unique opportunity to join the founding team of a rapidly growing MedTech startup. As a Quality and Regulatory Affairs Specialist, you assist and report directly to our Head of Quality and Regulatory, playing a critical hands-on role in both our product's success and our clients' success. You will prepare regulatory submissions, create quality management and technical documentation, directly engage with our clients, and contribute to the evolution of our AI-powered platform. If you want to be on the forefront of quality and regulatory affairs, medical technology, and AI technology, in an exciting growth oriented company, this role is for you. Position Responsibilities Your responsibilities will include:

• Provide expert regulatory and clinical guidance on documentation generated with our platform.
• Prepare regulatory submission packages, respond promptly to queries received during evaluation period and prepare correspondences regarding outcomes of submissions.
• Assist in client interactions beginning with onboarding through product development and submission as well as into post-market, providing information to clients under the guidance of our team.
• Collaborate with the CEO, CTO, and engineering teams to enhance our product, including the Formly eQMS and agentic offerings.
• Develop information guides, video guides, and other solutions for client to move through their regulatory journey smoothly and quickly while using Formly services.
• Contribute to the development and validation of new regulatory and quality tools within the Formly ecosystem.
• Assist the Head of Quality and Regulatory in daily operations.
• Monitor changes in legislation relating to medical device industry; stay abreast of emerging trends affecting regulatory landscape globally
• Optionally, perform detailed reviews of client technical documentation. Who You Are The ideal candidate will have the following qualifications and experience:
• A bachelors degree in engineering, life sciences, or a related field.
• 2-4 years of experience in regulatory affairs and/or clinical affairs within the medical device industry.
• Hands-on experience creating technical documentation (e.g., Clinical Evaluation Reports) for submission to an EU Notified Body or other competent authorities.
• Solid understanding of the EU Medical Device Regulation (MDR 2017/745).
• Working knowledge of key medical device standards (e.g., ISO 13485, ISO 14971, IEC 62304) and regulatory guidances (e.g., MDCG, IMDRF, FDA)
• Exceptional communication skills and a customer-centric mindset.
• Demonstrated ability to thrive in a dynamic, fast-paced environment; startup experience is a strong plus.
• Willingness to work flexible hours to accommodate clients across various time zones. Bonus Experience
• US FDA Code of Federal Regulations per requirements related to medical devices.
• Direct experience using or prompt engineering with AI Large Language Models (LLMs).
• Experience with both Software as a Medical Device (SaMD) and hardware medical devices.
• Broader quality systems experience (e.g., CAPA, post-market surveillance).
• Familiarity with Notified Body conformity assessments and audits.
• Familiarity with FDA Q-Submissions as well as 510(k), PMA and De Novo processes. Reports to Head of Quality and Regulatory Position location Fully Remote (European time zones preferred, US East Coast accepted with flexibility in working hours)

Compensation

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