Join the most committed people in IT
We are looking for
Principal Quality and Compliance Medical Devices Manager
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.
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
- 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.Send us a message
Meet the recruiter
WHAT YOU CAN GET
We support you at every stage
We've prepared life insurance on great terms for you.
Type of cooperation
An employment contract or B2B depending on your needs.
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.
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.
Decide on your development. Go to a conference, learn a new language or buy a selection of books in your field.
Recruitment process (run remotely but you're more than welcome to visit us at the office)
We carefully read every CV we receive. If you meet our requirements, we call you to learn more about your skills and needs.
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.
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.
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.