Cooperation
Collaboration with Medinice
Medinice is always open to new innovative solutions in the field of cardiology and cardiac surgery. We have experience and expertise in prototyping, testing including and clinical testing and certification.
If you are looking for a job in the MedTech sector or have an idea for a device, we invite you to contact us.
Do you have an innovative medical project?
Please contact us and tell us about your idea.
Are you looking for a job in MedTech industry?
Please contact us and present your CV.
WHO ARE WE LOOKING FOR?
Quality and documentation specialist
Responsibilities
– Creation of technical documentation in accordance with the applicable requirements for medical devices in the USA (FDA)
– Support in the creation of manufacturing documentation in accordance with FDA / MDR requirements
– Support in assessing the compliance of designed medical devices with US and EU regulatory and quality standards.
– Preparation of documentation for the registration of medical devices in the USA (FDA) / EU (MDR)
– Managing the registration process for medical devices on the US FDA / European MDR market
– Cooperation with product certifiers (GLP laboratories, pre-clinical and clinical studies, FDA, MDR)
– Supervision of the Quality Management System according to ISO 13485, ISO 9001 and FDA and MDR standards
– Oversight of medical device distribution – compliance with FDA or MDR obligations
– Close cooperation with the production (equipment prototyping) and office (product registration) departments
– Arranging, planning and conducting internal and external audits
– Identification of non-conformities and verification of corrective and preventive actions taken
– Preparation of reports
Our requirements
– University degree (preferred majors: pharmacy, biotechnology, medicine, engineering – or related).
– A degree in biomedical engineering or mechatronics would be an advantage
– Minimum 2 years’ professional experience
– Knowledge of standards related to ISO 13485 and FDA and MDR
– Good knowledge of spoken and written English
– Ability to work in a team
Nice to have
– Experience in obtaining FDA certification (510K) will be an added advantage
– Experience in ECA sterilisation will be an added advantage
– Experience in biocompatibility testing will be an added advantage
What is our offer?
– Attractive salary, employment contract or other form of work/cooperation
– Work in a friendly, collegial atmosphere in a truly ‘family’, non-corporate company
– Work in a dynamically growing company
– Opportunities for professional development through participation in training and courses
– Essential work tools
– Participation in an incentive programme and a package of additional benefits
– EMPLOYMENT OR B2B full-time contract
– Office work
Senior Manager Regulatory Affairs (FDA) – fluent English required
Join our team and collaborate with experts in a rapidly growing company in the medical device industry!
Job Responsibilities:
Creating and updating technical documentation in compliance with FDA regulations.
Supporting the assessment of medical device conformity with legal standards
Managing the registration process for medical devices in the US (FDA).
Collaborating with GLP laboratories, certifying bodies, and internal departments.
Planning and conducting internal and external audits.
Identifying non-conformities and overseeing corrective and preventive actions.
Requirements:
Higher education (preferably in pharmacy, biotechnology, biomedical engineering, medicine, or related fields).
At least 5 years of professional experience.
Knowledge of ISO 13485, FDA regulations.
Experience with FDA submissions (e.g., 510(k)).
Experience in medical devices class II (FDA)
Good communication in English (spoken and written).
Ability to work effectively in a team, self-driven
Nice to Have:
Knowledge of ETO sterilization processes.
Experience in biocompatibility testing.
Experience in medical devices class III (FDA)
Experience with MDR
What We Offer:
Engagement in design and development of life saving devices Competitive salary.
Employment contract or another form of cooperation tailored to your preferences.
Opportunities for professional development through training and courses.
Friendly, team-oriented atmosphere in a dynamic company.
Necessary tools for work and a benefits package (e.g., incentive programs).
Join our team and develop your career in the medical device industry!
