Regulatory specialist

Boule Diagnostics AB is a global diagnostics company that develops, manufactures and markets instruments and consumable products for blood diagnostics. The company serves hospitals, clinics, laboratories and companies within blood diagnostics, in both human and veterinary hematology. The company operates via subsidiaries in Sweden, the USA, Mexico and Russia. The company products are sold globally primarily through distributors, supported by Boule’s own local sales and support personnel. The Boule shares are listed on Nasdaq Stockholm since 2011.

We are expanding our QARA team and are now looking for a Regulatory specialist!

If you are looking for an exciting new role in a changing environment where you get to be part of shaping a strong QARA department, then read this!

This role is a full time employment and the primary location is Spånga, Stockholm.

The role will be mainly concentrating on the following areas:

• Plan and perform vigilance activities, e.g., authority contacts, recalls, advisory notices etc.
• Communicate with Notified Body and authorities regarding substantial system changes and new product designs
• Review design dossier/technical file and labeling for regulatory approval at new designs and change managements
• Keeping list of applicable laws and regulations updated
• Ensure that processes needed for regulatory compliance in the quality management system are documented
• Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization
• Participate in new development projects to perform review of device-specific and region-specific regulations applicable for the new device
• Participate in projects related to entering new markets to identify applicable and necessary region-specific regulations and approvals

Who You Are

We are looking for a person who can be trusted with meeting deadlines and takes accountability and responsibility for your work, is pro-active with a positive can-do attitude, and solution oriented if there are needs to improve the way of working.

Ideal candidate for this position

• Experience within regulatory area and/or technical documentation for medical devices
• Familiar with applicable product standards in the field of IVD
• Good knowledge of medical device registrations
• Fluency in the English language and is comfortable communicating in Swedish, in speech and in writing

On top of being part of a great QARA team in an important and fun role we can offer a friendly environment with great employee benefits! Selection takes place continuously so send in your application right away!

If you have any questions related to the role or the life at Boule, kindly connect with responsible department manager Niklas Lundqvist at niklas.lundqvist@boule.com or HR at HR@boule.se.