Regulatory
Lead Regulatory Compliance Specialist
We're a remote-first company that gathers folks passionate about redesigning healthcare for millions of people on the planet. If you are led by an ambition to make a good impact in the surrounding world - we would love to meet you.
Location
Infermedica is a remote-first company. So why do you see a particular location here? To boost the outreach, we advertise our jobs on external job boards that require us to specify the location.
Nevertheless, nothing has changed; we are and will remain remote-first.
Commitment
Full time
Salary
up to 26 000 PLN + VAT/B2B
up to 22 000 PLN gross/UoP
Your Impact
We are looking for a strategic Lead Regulatory Compliance Specialist who will own our regulatory landscape and navigate the complexities of MDR and ISO 13485:2016 to keep our AI-driven SaMD solutions compliant and competitive. This is a high-autonomy and more than a compliance role; it is an opportunity to act as a bridge between complex legal frameworks and product innovation.
Responsibilities
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Owning regulatory landscape at Infermedica
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Advising on the company’s compliance with laws and regulations, and managing the company’s actions in meeting regulatory requirements in foreign jurisdictions
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Continuous monitoring of regulations and requirements in the European Union and other jurisdictions where our products are available
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Creating, implementing, and maintaining documentation and policies relevant to the company’s operations. Ensuring the documentation and procedures are thorough, understandable, and up to date
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Collaborating with Product and contributing regulatory insights to the product roadmap
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Owning the correspondence with URPL and other actors in the regulatory processes
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Supporting team members with regulatory concerns, especially collaborating closely with the commercial team to support client-related topics
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Participation in the MDR certification of software as a medical device
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Leading product registration in various countries
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Cooperation with external consultants
Role requirements
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Medical, technical, or legal education
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At least 4+ years of experience in a position related to medical device compliance
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Deep understanding of European and Polish legislation regarding medical devices, specifically the MDR. Knowledge of the regulatory landscape in other jurisdictions will be beneficial (e.g., the US, the UK, Australia, and Switzerland)
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Experience working within an ISO 13485:2016 certified Management System as well as ability to create and maintain technical documentation and procedures compliant with ISO 13485:2016
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High proficiency in using English and Polish for both written and spoken communication
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Experience in managing compliance for AI-driven medical devices and/or Software as a Medical Device will be beneficial
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Being a certified auditor for ISO 13485 will be beneficial
Location
Infermedica is a remote-first company. So why do you see a particular location here? To boost the outreach, we advertise our jobs on external job boards that require us to specify the location.
Nevertheless, nothing has changed; we are and will remain remote-first.
Commitment
Full time
Salary
up to 26 000 PLN + VAT/B2B
up to 22 000 PLN gross/UoP
Perks & benefits
Remote work and flexible working hours
Choice of the most comfortable type of contract
Mental health support provided by Mindgram
Buddy program to support our new joiners
Annual holiday allowance of 20 or 26 days
Additional paid vacation days depending on tenure
Employee Stock Ownership Plan - own part of the company
Full IT equipment to set up your home office
Recruitment process
We keep things simple but effective. Our recruitment process is no different, even though we adjust the approach depending on the role and its complexity.
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Sending applications
Simply click the ‘apply’ button and fill out the application form.
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Verification of applicants
Not every application is successful, but we inform everyone.
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Meeting with the Talent team
Use this time to ask questions and learn more about us.
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Meeting with the team
Meet your future manager and team members.
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Task
In some cases we ask you to complete a test task.
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Final meeting
Meet the exec team representative for your role, after which we will make the final decision and discuss details.
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Reference meetings
Reference sessions are conversations with your colleagues or direct reports from previous workplaces.
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