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Consultant in Quality and Regulatory Affairs (QA/RA) Health Care

You enjoy dealing with quality and regulatory issues. Especially if the issues are also about medical devices and patient safety. The challenge of transforming complex regulations into something easily understandable and functional is something that makes your heart beat a little faster. You want to go there, to the Location, where your skills can shine and be seen and you can share your interests with like-minded people. Did we just describe you? Great! Then you could be our next Healthcare Compliance consultant.

This is your role
You will work with our clients in both the private and public sector and support them in their organizations. You will lead projects, work on applications, inspections, regulations, clinical evaluation, standards and sit on development projects. Being a consultant in this role requires responsibility and can be challenging, but is above all very fun! The role gives you a lot of room to influence your own development through the assignments you work on.

  • You will guide our customers through the regulatory world.
  • You will be part of the Healthcare Compliance unit.
  • You will share your assignments between both the private and public sectors and see the entire chain of a medical device - from manufacturing to use in healthcare.
  • You will take a natural Location in a team that likes to talk quality, regulatory compliance and project management.
  • You will be part of a team that is growing, flexible and loves to share its knowledge!

We would like you to live in Stockholm, Lund, Malmö or Uppsala but location is not essential for the role.

How you will shine
We shine by sharing our knowledge and so will you. Through your social and communication skills, you will build trust with the people you meet. You have the ability to make complex information easy to understand while ensuring accuracy and quality in everything you do. You are independent with good self-leadership, although you enjoy being part of a team and working with colleagues who are passionate about the same issues as you are.

If you have the following qualities, we believe you are suitable for this role:

  • You have at least 4 years of experience in quality management and/or regulatory affairs in Medtech/IVD or healthcare.
  • You have a college or university degree in Life Science (Bachelor of Science, Master of Science, BMA or PhD) or can demonstrate equivalent work experience.
  • You are comfortable speaking and writing both Swedish and English at a high level.
  • You have a driving license.

If you also have experience in one of the following areas, you will excel with us:

  • You have worked with one or more of the following: MDD/MDR, IVDD/IVDR, ISO 13485, ISO 15189, TR 80002-2, ISO 14971.
  • You have worked in a medical technology department in a hospital.
  • You have worked with self-manufacturing in healthcare according to MDD/MDR or IVDD/IVDR.
  • You have experience with quality management systems and have worked with e.g. deviation management, CAPA and inspections.
  • You work on the development, update or assessment of technical documentation related to medical devices.
  • You have experience in digitalization, running digitalization projects in healthcare.
  • You have experience working with National Medical Information Systems (NMI).

Being part of Team PV
We are very proud to be a certified Great Place To Work company, which means we can count ourselves among the best employers in the whole country. The fact that we are also on the top list of Sweden's Best Workplaces can only be seen as proof that together we have succeeded, and continue to succeed, in creating a fantastic culture.

Because we actually think we're different from traditional consultancies. Partly for the solutions we develop and partly for the way we develop them. And the key to both is the people who work here. Over the years, we've become a workplace that attracts the sharpest minds and the finest hearts. There's a saying that a culture is in the walls. With us, it's a warmth. In a way, we have soft walls.

Our clients meet us either as consultants in their own organization, as advisors or when we manage the entire project delivery. No matter how, where or when they meet us, they get a person who cares both about their results and their new colleagues.

As our colleague you will, among other things:

  • a secure job with a fixed monthly salary
  • a strong culture of personal and professional development
  • flexible working environment and great freedom under responsibility
  • benefits, health allowances and health examinations
  • occupational pension and 30 days' holiday
  • compensation for parental leave

Application
If you think we are the right workplace for you and you are right for us, send in your application today! Selection is ongoing. Access takes place according to agreement.

If you have any questions about this post, please contact Pascal Skoglund on 072 566 99 87, pascal.skoglund@plantvision.se, or Beatrice Orback on 076 138 52 14, beatrice.orback@plantvision.se.

For this recruitment, we have adopted a strategic approach and therefore refrain from calls from recruitment, staffing and advertising companies.

About this position

Team: Compliance
Location: Stockholm

What is our recruitment process?

We are proud of our recruitment process. We employ some of the best in the business and it all starts there, in a way, with a fair and evidence-based process. It's like the backbone of our delivery because it helps us ensure that we can deliver the best solutions to our clients. Because by following every step, we can be sure that you are the person we are looking for. No matter who you are or what you've done before - if you fit the profile, we welcome you!

Step 1
selection

We will review your application, examining how well you match the position based on skills, potential and your described personal qualities.   

Step 2
Interview

Initially, we'll have a first conversation over the phone, after which you'll meet with the responsible manager, parts of your team and HR. 

Step 3
Tests and references

Through testing, we ensure evidence-based recruitment. As a final step, we collect your references.

Step 4
Offer

Hooray! We seem to be a perfect match for each other. Then you are offered a job with us. 

Step 5
Onboarding

Already after signing the contract we start the introduction to us. We want to give you the best possible start on your exciting new journey with us!

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