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We are looking for

Principal Quality and Compliance Medical Devices Manager

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Team size

3-5

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Location

Bialystok
Cracow
Warsaw
Wroclaw

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Experience

Senior

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About Spyrosoft

Currently named the fastest growing technology company in Europe by the Financial Times, we were founded in 2016 by a group of IT experts with established backgrounds in software engineering. We specialise in technology solutions for industry 4.0, automotive, geospatial, healthcare & life sciences, employee experience & education and financial services industries. Our teams are based internationally - Poland (Wrocław, Kraków, Białystok, Warsaw), UK (Bournemouth), Germany (Brunswick, Munich), Croatia (Zagreb), USA (Ann Arbor) and India (Vadodara).

Project description

We are searching for a regulatory specialist with experience in (software) medical devices to participate in our projects and take responsibility of MDR, FDA submission.
Experience with medical devices and submission is necessary for this role. We strongly prefer someone with experience in EU MDR and FDA, deeply experience in ISO 13485.

Job description

The Regulatory Specialist will provide direct regulatory support to various medical projects and products, both new and existing. Responsibilities may include:

  • Preparing regulatory strategy, registration, notification, and pre-market submission requirements, including the necessary regulatory documents.
  • Supporting strategic regulatory planning and product development efforts
  • Managing product lifecycle from pre-market to post-marking phase
  • Providing regulatory guidance to our business partners and liaising with RA teams
  • Ensuring compliance of the medical device products (MDR, FDA, ISO 13485, IEC 62304)
  • Managing medical device risk management activities related to ISO 14971
  • Taking over responsibility of regulatory consultancy related to medical devices incorporated with the software

Requirements

  • Minimum of a B.A. /B.S. within a technical related discipline is required
  • Minimum of 2 years of experience in Regulatory Affairs or Master’s degree with equivalent experience
  • Ability to work both independently and in a team environment. Ability to problem-solve, recognize and find solutions for gaps in processes
  • Knowledge of FDA Regulations and CE Marking Requirements, ISO 13485
  • Excellent communication skills (verbal and written)
  • Strong organizational skills
  • Project management skills
  • Problem-solving skills
  • Presentation skills

Do you know anybody who would fit the role?

Great! Contact our recruitment team and get PLN 5000.

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    Meet the recruiter

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    Ola_trojkat (1)
    Building a new team is a puzzle, there’s no room for mistakes.
    Aleksandra Surmińska
    Recruitment Specialist

    WHAT YOU CAN GET

    We support you at every stage

    Check out the benefits of working at Spyrosoft

    Group insurance

    We've prepared life insurance on great terms for you.

    Type of cooperation

    An employment contract or B2B depending on your needs.

    Multisport card

    Crossfit or pilates? With the card you can enter selected gyms for free.

    Flexible working hours

    You're not an early bird? You can work for us when you are the most productive.

    Remote work

    In most projects, each specialist can work one day a week from any location.

    Private health care

    We have several packages from two suppliers to choose from, without waiting in queues.

    Choice of equipment

    You choose which equipment will work best for you.

    Budget

    Decide on your development. Go to a conference, learn a new language or buy a selection of books in your field.

    Apply now

    Recruitment process (run remotely but you're more than welcome to visit us at the office)

    Proces rekrutacyjny icon
    01
    We check your CV

    We carefully read every CV we receive. If you meet our requirements, we call you to learn more about your skills and needs.

    Proces rekrutacyjny icon
    02
    We check your qualifications

    After talking on the phone, it's time for the technical part of recruitment, during which we can ask you to complete the task related to your position. We always provide feedback after this meeting.

    Proces rekrutacyjny icon
    03
    We make an appointment

    The next stage is a meeting in one of our offices or online. You will have the opportunity to learn more about the team and work culture from the person who manages the department and/or Spyrosoft partner.

    Proces rekrutacyjny icon
    04
    You get the answer

    At Spyrosoft, we contact every person who was taking part in recruitment process. If we accept your candidacy, we will also send you a list of the next steps.