Senior Regulatory Affairs Manager

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 EU and US and are backed by both 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 MDR and FDA, who wants to impact one of the most important shifts in modern medicine.

Your Role

  • Lead the regulatory strategy of our innovative medical devices
  • Own general project management of our regulatory agenda
  • Manage, and prepare critical regulatory submissions
  • Develop and lead QMS processes on regulatory affairs topics
  • Manage our external regulatory consultants
  • Own communication with regulatory bodies, incl. FDA and EU Notified Body
  • Oversee the preparation of all necessary reports within the post-marketing surveillance activities
  • Monitor and analyze changes in regulations and ensure their effective implementation across departments

Your Profile

  • 5+ years of experience in regulatory affairs and quality management
  • In-depth knowledge of the US FDA and EU MDR regulatory landscape
  • Experience with Software as a Medical Device and its regulatory implications with regard to software development, risk management, human factors engineering, and device architecture topics
  • Successfully led regulatory submissions under FDA and EU MDR
  • 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

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