Senior Regulatory Affairs Specialist
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Regulatory Affairs Specialist based in United States.
This is a high-impact regulatory role supporting the development and global expansion of innovative medical devices and digital health technologies.
You will help shape regulatory strategy for AI-powered software, connected hardware, and clinical technologies used by healthcare professionals worldwide.
The role combines regulatory remediation, quality systems, global market access, and cross-functional product support.
You will work closely with engineering, clinical, quality, and commercial teams throughout hardware and software development.
Your expertise will help ensure products meet evolving regulatory requirements while supporting efficient international expansion.
This is an opportunity to contribute to technologies designed to improve the detection and management of cardiovascular and pulmonary conditions.
The position is ideal for an experienced regulatory professional who thrives in a fast-paced, innovation-driven environment.
Accountabilities:
- Lead QMS and regulatory remediation initiatives, aligning global procedures into unified and streamlined workflows.
- Revise and consolidate SOPs covering Design History Files, design and development documentation, Post-Market Surveillance, Labeling/UDI, EUDAMED, and global regulatory strategy.
- Support compliance with FDA QMSR and ISO 13485 requirements.
- Drive regulatory documentation cleanup and maintain the Global Regulatory Submissions & Deficiencies Database.
- Develop and execute regulatory strategies and submissions across the EU, UK, Canada, APAC, and LATAM markets.
- Manage interactions with Notified Bodies and EU Authorized Representatives for technical file reviews, Notifications of Change, and DoC/CE updates.
- Support regulatory evaluation and intelligence mapping for veterinary product expansion across international markets.
- Serve as the Regulatory Affairs representative on cross-functional teams supporting hardware and AI/software releases.
- Standardize claims matrices, IFU restrictions, and advertising and promotional review processes.
- Evaluate and implement Regulatory Information Management Systems and AI-enabled regulatory workflows.
- Monitor compliance with applicable regulations, internal policies, and quality standards.
- Bachelor’s or Master’s degree, or other advanced degree, in Engineering, Life Sciences, Regulatory Affairs, or a related technical discipline.
- 5-8+ years of progressive regulatory affairs experience in medical devices, digital health, and/or SaMD.
- Strong working knowledge of FDA 21 CFR 820/QMSR, EU MDR 2017/745, ISO 13485, and global regulatory submission requirements.
- Direct experience preparing and submitting 510(k)s, Q-Subs, De Novo submissions, and Technical Files.
- Experience managing Notified Body reviews and international regulatory interactions.
- Proven track record leading major QMS remediation programs and global market-entry initiatives.
- Strong communication, organizational, analytical, and problem-solving skills.
- Ability to collaborate effectively with technical, clinical, quality, and commercial stakeholders.
- RAC certification is preferred.
- Experience working in a startup or high-growth environment is preferred.
- Ability to perform the essential functions of the role with or without reasonable accommodation.
- Fully remote position within the United States, with expected travel.
- Generous paid time off.
- Stock incentive plan.
- Medical, dental, and vision insurance.
- Disability and life insurance.
- One Medical membership.
- Parental leave.
- 401(k) matching.
- Learning and development stipend.
- Opportunity to contribute to healthcare technologies designed to improve patient care at scale.
- Work alongside a multidisciplinary team spanning engineering, medicine, research, and technology.
In this role, you will lead key regulatory initiatives across quality systems, product development, international registrations, and commercial activities, helping establish consistent and scalable regulatory processes.
Requirements:
The ideal candidate brings substantial regulatory affairs experience within medical devices, digital health, or Software as a Medical Device, combined with strong knowledge of U.S. and international regulatory frameworks.
Benefits: