Director of Regulatory Affairs

At Powerful Medical, we are building a global life-saving technology. Our certified product diagnoses cardiovascular diseases (#1 cause of death globally) by scanning ECGs using AI and machine learning. We’re currently cooperating with several leading healthcare providers within the US and the EU and are backed by US, European, and Israeli VCs.

You will own the Regulatory area at Powerful Medical. You will ensure proper compliance and alignment with regulatory standards for our already certified products and lead the certification of new ones. For this important role, we are looking for a seasoned professional, experienced with both FDA and MDR, who wants to impact one of the most important shifts in modern medicine.

Your role

  • Lead the regulatory strategy of our innovative medical devices and own their regulatory submissions and approvals.
  • Work with senior leadership, cross-functional teams and external consultants on regulatory strategy for US, EU, and international markets ensuring early consideration of regulatory requirements.
  • Prepare and coordinate regulatory submission filings for Class 2 devices. Draft and file 510(k)s, De Novos well as pre-submissions (Q-subs), IDE requests and reports, and post-market reports.
  • Support our product development and engineering team in the implementation of regulatory requirements, including preparation and review of design and test documentation, assessment of product changes, and interpretation of guidance and standards.
  • Provide regulatory review/approval for promotional materials, press releases, and corporate presentations for compliance
  • Maintain and expand current knowledge of FDA, EU, and international regulation, guidance and standards applicable to company products. Advise the company on any changes to Regulations or Standards that would affect our regulatory strategy or business objectives.
  • Own communication with regulatory bodies, incl. FDA and EU Notified Body, and coordinate internal and external audits.
  • Review and approve all design control documentation, engineering change requests for design, manufacturing, labeling changes, and product releases to ensure compliance with FDA, EU, and international government regulations.

Your profile

  • 5+ years of experience in regulatory affairs and quality management
  • Biomedical, clinical or software engineering (or equivalent scientific discipline) to degree level
  • In-depth knowledge of the US FDA and EU MDR regulatory landscape
  • In depth knowledge 21 CFR 820, IEC 62304, ISO 62366-1, ISO 13485, and ISO 14971.
  • History of successful 510(k), De Novo’s, IDE, and/or PMA device submissions. Other worldwide submissions and clearances are a plus.
  • Experience with new product development projects for software as a medical device (SaMD) or medical device component. Ability to review and provide critical feedback on design documentation.
  • Excellent command of the English language
  • Ability to communicate and interact with regulatory agencies and consultants
  • Excellent project management skills
  • Experience in growing and managing high-performing and multi-disciplinary teams
  • Display, encourage, and inspire a culture of excellence across the entire organization

Nice to have

  • Knowledge of MDSAP and International regulatory experience in other leading markets, such as Australia, Canada, Japan, or Brazil
  • Experience with AI/ML-based medical devices
  • Experience with cardiology medical devices

Join us

Give your best where it matters the most. 

What we offer.

Along with the chance to collaborate with bright and skilled individuals on a mission to save lives, we also provide a variety of appealing benefits.

ESOP (Employee Stock
Ownership Plan)

ESOP (Employee Stock Ownership Plan)

We grant restricted stock to every team member based on their seniority and time with the company. Your ESOP allocation depends on the current company valuation.

Office with view in
Bratislava Downtown

Office with a view in Bratislava Downtown

Our environmentally friendly office provides stunning views and comes with perks such as complimentary fruits, snacks, Friday lunches, monthly breakfasts, and a premium coffee machine.

Physical
& Mental Health

Physical & mental health

We prioritize your well-being, providing access to consultations with a psychologist or coach for both work and personal matters.  You also receive a monthly 30€ contribution towards a Multisport card or a book of your choice.

Referral
Bonus

Referral
bonus

Help us attract top-notch talent and be rewarded for your efforts. If the person you refer joins our team, you’re eligible for rewards, with options like electronics or a trip worth up to 1,000€.

Hardware
Bonus

Tech equipment allocation

As a full-time employee, you will receive a company notebook and monitor. Additionally, you can choose extra equipment to ensure you have everything you need for your workspace.

ESOP (Employee Stock Ownership Plan)

We grant restricted stock to every team member based on their seniority and time with the company. Your ESOP allocation depends on the current company valuation. 

Our eco-friendly office offers a great view and includes perks like free fruits, snacks, Friday lunches, monthly breakfast, and a top-notch coffee machine. 

We prioritise your well-being. You can consult with a psychologist or coach for any work or personal matters. Plus, you get a 30€ contribution for a Multisport card or the option to order a book of your choice. 

Help us find top talent and earn rewards. If your referral is hired, you could receive hardware or even a trip worth up to 1,000€. 

As a full-time employee, you’ll receive a company notebook and monitor. You can also select additional equipment or devices when you join.

Who we are

At Powerful Medical, our values aren’t just words on a wall; they’re the driving force behind everything we do 🧨. We’re a team of game-changers, dreamers, and doers. Join us and save lives with us!

Fearless Innovation

Fearless Innovation

We dare to dream, disrupt, and pioneer transformative solutions that redefine industry standards.

Passion for Impact

Passion for Impact

We’re passionate about making a meaningful difference in the world, pushing boundaries of modern medicine, and leaving a lasting legacy.

Transformative Collaboration

Transformative Collaboration

We thrive on connecting brilliant minds, fostering an environment where great ideas flourish through collaboration.

Entrepreneurial Spirit

Entrepreneurial Spirit

We don’t just face challenges; we embrace them, pivot with change, and are always on the lookout for the next opportunity to grow and evolve.

Fearless Innovation

We dare to dream, disrupt, and pioneer transformative solutions that redefine industry standards.

We’re passionate about making a meaningful difference in the world, pushing boundaries of modern medicine, and leaving a lasting legacy. 

We thrive on connecting brilliant minds, fostering an environment where great ideas flourish through collaboration.

We don’t just face challenges; we embrace them, pivot with change, and are always on the lookout for the next opportunity to grow and evolve.

People of Powerful Medical

Related jobs

Commercial Operations Specialist
Bratislava, Slovakia
Full-time
Clinical Specialist
EU (Remote)
Full-time
Sales Development Representative
Bratislava, Slovakia
Full-time
Director of Regulatory Affairs
US (Remote)
Full-time