Medical Device Regulatory Coordinator
Coordinate Pulsetto’s FDA & EU MDR documentation, align teams, and work with consultants to remove bottlenecks - keeping certifications moving fast with complete, consistent, on-time info.
About Pulsetto
Pulsetto is one of the fastest-growing wellness device companies, helping people around the world — from the US and UK to Europe and Australia — reduce stress and sleep better with innovative vagus nerve stimulation (VNS) technology.
You may have seen us on Netflix’s “Don’t Die”, our founder’s Shark Tank pitch, or even heard that Cristiano Ronaldo and top NBA players use Pulsetto for recovery.
Despite the spotlight, we’re a humble team of 50+, working closely with researchers and medical professionals from around the world to advance the scientific understanding of non-invasive vagus nerve stimulation.
Our main focus is the clinical evaluation of Pulsetto’s technology — building strong evidence through collaborations, studies, and data-driven innovation.
We are now looking for a Medical Device Regulatory Coordinator to help accelerate and streamline our FDA and EU MDR certification processes.
Position Overview
The Medical Device Regulatory Coordinator is responsible for coordinating and managing Pulsetto’s medical device regulatory documentation and compliance activities. The role focuses on reviewing existing FDA and EU MDR documentation, collecting and structuring information across internal teams, and ensuring timely, high-quality collaboration with external regulatory consultants.
This is a highly execution-focused role. The main objective is to remove internal documentation bottlenecks, improve regulatory readiness, and ensure that certification processes move forward without delays caused by missing, inconsistent, or unreviewed information.
Your Day-to-Day:
Review and manage documentation related to FDA 510 (k) and EU MDR medical device certification.
Collect, consolidate, and structure regulatory inputs from internal teams (R&D, software/app, medical, clinical, quality).
Coordinate documentation reviews, revisions, and feedback cycles with external regulatory consultants.
Track documentation status, versions, gaps, and dependencies to ensure certification readiness.
Maintain version control, traceability, and consistency across all regulatory documents.
Monitor updates to relevant medical device regulations, standards, and guidance, and assess their impact on Pulsetto’s documentation and processes.
Support implementation of regulatory updates internally, in collaboration with responsible teams.
Help prepare documentation for audits, reviews, and certification milestones.
Proactively identify bottlenecks and drive corrective actions to keep regulatory work moving forward.
What we are looking for:
At least 2 years of experience in regulatory coordination, project coordination, quality, compliance, or documentation-heavy roles, ideally in medical devices, life sciences, or health tech.
Education in health sciences (e.g., health sciences, biomedical sciences, neuroscience, or a closely related field).
Strong organizational and basic project management skills, with the ability to structure tasks and follow timelines.
Ability to read, understand, and work with regulatory and technical documentation (FDA, MDR, standards, technical files).
Strong organizational and project management skills, with attention to detail and follow-through.
Ownership mindset — able to independently drive tasks to completion and remove blockers.
Ability to work across multiple teams and coordinate inputs without micromanagement.
Structured thinker with a problem-solving approach.
Strong written and spoken English.
Soft skills we value:
Ownership & Accountability – Takes full responsibility for outcomes.
Adaptability – Thrives in speed, ambiguity, and change.
Proactivity – Anticipates opportunities and acts without waiting.
Common Sense & Prioritisation – Focuses on what drives real profit.
Solution-Oriented Mindset – Brings tested ideas, not just problems.
Collaboration & Communication – Works closely across teams with clarity and respect.
What We Offer:
A high-impact role with real ownership and responsibility
A supportive environment tailored to this role — with clear priorities, structured processes, and hands-on support to succeed in execution-focused work.
Collaboration with an ambitious, international team.
Hybrid work model – 3 days in the office (Vilnius) or fully remote if based elsewhere.
Office perks for the Vilnius team – including free lunch 3 times a week.
Pulsetto device – support your well-being daily.
Health insurance – provided after 6 months from your start date
Extra days off.
Birthday day off – celebrate on your terms.
📍 Location: Vilnius / Hybrid
🕐 Employment Type: Full-time
💰 Gross Salary: €2100–€3,100 gross per month (depending on experience)
- Department
- Clinical
- Locations
- Vilnius, Lithuania
- Remote status
- Hybrid
About Pulsetto
Pulsetto is redefining wellness with technology that calms the body and empowers the mind. Through vagus nerve stimulation, our device helps people reduce stress, sleep better, and strengthen both physical and mental health—naturally and effortlessly.
Featured on Netflix, trusted by Cristiano Ronaldo and Domantas Sabonis, and loved by 100,000+ users worldwide, Pulsetto is shaping the future of wellness.
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