Medical Device Compliance Specialist

Wrocław  / Remote work / Telecommute · Legal

Job openings     Medical device compliance specialist

Medical Device Compliance Specialist

We are looking for an experienced Medical Device Compliance Specialist to join Infermedica’s legal force. If you have a proven track record in ensuring compliance with medical device regulations, have a good understanding of personal data protection and processes related to the implementation and maintenance of ISO norms, you are the person we are looking for.

Requirements


We are looking for a Compliance Specialist who could take full responsibility for ensuring that the company adheres to all industry-relevant legal requirements and internal policies. The ideal candidate should be able to demonstrate:

  • at least 3 years of experience on a compliance-related position and ideally 5 years in legal assistance in the medical device industry 
  • Very good knowledge of national and European medical device regulations
  • Very good understanding of the principles of entering medical devices into foreign markets
  • ISO certification experience
  • Very good orientation in the national medical device registration and notification procedure, a knowledge of medical device procedures before foreign offices is a strong asset
  • Sound knowledge of personal data protection regulations
  • A Master’s degree in Law
  • Diligence and attention to detail
  • Fluency in English and Polish


Additionally, it would be great if you have the experience or willingness to get familiarized with:

  • US HIPAA and FDA requirements related to medical devices
  • ‘Software as a medical device’ regulatory requirements

Responsibilities


As a Compliance Specialist, you will be a part of the Legal Team at Infermedica and will report to the Head of Legal. You will also work closely with other teams at Infermedica to ensure that the company is in compliance with all the relevant regulations and standards in all operations. Your daily tasks will include the following:

  • Developing, frequently reviewing and auditing company medical device and GDPR policies, procedures, practices, and documents
  • Implementing and managing an effective legal compliance program with action plans in response to audit discoveries and compliance violations
  • Auditing the company’s undertakings and documents to identify possible weaknesses or risks
  • Implementing and maintaining ISO 13485 certification and assist in the implementation and maintenance of ISO 27001 certification
  • Advising on the company’s compliance with laws and regulations, and manage the company’s actions in meeting regulatory requirements in the foreign jurisdictions
  • Creating, implementing, and maintaining documentation and policies relevant to the company’s operations
  • Increasing the company’s personnel members’ awareness regarding the medical device, and GDPR regulations and requirements
  • Resolving concerns about compliance with legal requirements and internal standards
  • Ensuring the company’s actions and documents are GDPR-compliant
  • Focusing on data protection in performing all responsibilities
  • Supporting the company’s legal team in other daily activities

Offer


We are committed to building an open and supportive environment where you can do your best work and improve your abilities. You will be working with great people, and we will help you lead a healthy life outside of the office. What benefits do we provide?

  • An Employee Stock Ownership Plan which allows you to become an Infermedica shareholder
  • Flexible forms of employment
  • Flexible working hours
  • Any equipment you need
  • The ability to work remotely
  • Paid vacations (also for B2B)
  • Private healthcare (PZU Zdrowie)
  • Free consultations with a doctor in our office
  • A development budget
  • MyBenefit System (incl. Multisport) Lunch discounts
  • Lunch discounts


Next steps

If this sounds like a good fit for you, apply now by clicking the button below. Please do not forget to attach a CV to your application. If you wish to share more information you are free to include links to your business social media profiles.

We will review all applications and arrange an online chat with selected candidates. Unfortunately, not all of you will be invited for an on-site interview but we always provide feedback to all candidates regardless of our decision.


How will the recruitment process look like?

  • Your application
  • Phone screening with chosen candidates
  • Interview with the Head of Legal 
  • Final stage - meeting with COO
1 vacancy

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