Regulatory Affairs Specialist

4 tygodni temu

Weissa Kraków, Polska Cardiomatics Pełny etat
Job Title: Junior Regulatory Affairs and Quality Specialist

We're on a mission to bring AI to cardiac diagnostic and treatment. Our team is passionate about digital health and new technology, and we're looking for a talented individual to join us in shaping the regulatory and quality landscape of our class IIa medical device.

Responsibilities:
  • Ensure compliance of our product with the Medical Device Regulation (MDR) 2017/745.
  • Prepare and implement regulatory and quality processes within the company.
  • Update and maintain technical documentation.
  • Monitor, analyze, and evaluate quality indicators, audits results, feedbacks, and risk management activities.
  • Implement corrective and preventive actions and improvements in the quality system.
  • Communicate with Notified Bodies, Competent Authorities, and Authorized Representatives.
  • Collaborate with cross-functional teams to ensure regulatory compliance and high product quality throughout the software development life cycle.
  • Conduct internal audits and organize external audits and inspections.
  • Register devices in new markets and ensure ongoing compliance in existing markets.
Requirements:
  • Advanced verbal and written English language skills.
  • University degree (final-year students are welcome).
  • Eager to learn how to interpret standards and regulatory provisions.
  • Eager to work with documentation and technical files.
  • Analytical capabilities, problem-solving skills, attention to detail, and ability to operate independently.
  • Thrive for self-development and willingness to take on new challenges.
Nice to Have:
  • Experience in regulatory affairs within the medical device industry or related.
  • Knowledge of ISO 13485 or ISO 9001.
  • Knowledge of Medical Device Directive or Medical Device Regulation (MDR 2017/745).
  • Knowledge of FDA Current Good Manufacturing Practice (CGMP) regulation.
  • Knowledge of quality management systems and software development processes, especially related to medical devices.
We Offer:
  • Work in a professional, collaborative, and supportive environment.
  • Gaining experience with the regulatory and quality aspects of revolutionary technologies (AI, cloud software, SaaS).
  • Lots of interesting challenges that will develop you professionally.
  • Flexible working hours, ability to use our office or remote work.
  • Startup culture environment, great atmosphere for open-minded people.
  • Training budget.
  • Attractive compensation package with bonus component.
  • Employee Stock Options Plan.

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