Director Quality and Regulatory Affairs, Integrum, Gothenburg

Since its start in 1998, Integrum AB has been helping individuals with amputations get improved quality of life. Decades of scientific research and development within the field of osseointegration has generated the OPRA TM Implant System for bone-anchored prostheses. This unique approach, utilizing implants of titanium alloy and scientifically well documented concept of osseointegration, offers significant advantages for the patient compared to traditional socket prostheses. Among these advantages are the ability to once again feel the ground beneath your feet, avoid the pain and discomfort of a chiding socket, and to wear the prosthesis for a longer period every day.

We are currently looking for a Director Quality and Regulatory Affairs to lead the QA&RA team and enable continued international growth. The overall responsibilities include to ensure that the QMS is suitable, effective, and up to date, being the official contact with regulatory authorities, and to plan and perform to fulfil regulatory requirements for market access. In the role, you will lead a team of three, report to the CEO and be a part of the Management team.

The ideal candidate is driven, structured and reliable in delivering results. We are looking for a leader with interpersonal skills, able to combine regulatory and quality requirements with business acumen. Someone who likes challenges and to manage change. If you also have a positive mindset and are a proactive team player, we will be happy to get in touch with you!

Key responsibilities:

• Develop and maintain company regulatory strategy
• Maintain and improve QMS effectiveness and suitability
• Being responsible for regulatory compliance
• Line manager QA/RA team
• Implement and plan projects, organize project teams, communicate with internal and external contacts
• Monitoring new regulatory requirements as well as changes to existing regulations on worldwide basis
• Secure regulatory requirements and documentation
• Plan and perform regulatory submissions and updates worldwide to achieve market access
• Contact and coordination with authorities both nationally and globally

Your background and competencies:

We are looking for candidates with a solid experience from Regulatory Affairs in the Life Science Industry and a relevant university degree. You have knowledge about the regulatory regulations, especially in Europe and the US, together with experience from evaluation and compilation of the legislation needed for approval of new products and change matters. In this role you will need the freedom to travel, both domestic and internationally, together with excellent communication skills in both Swedish and English.

In this recruitment Integrum cooperates with Maquire. We welcome your application with CV and cover letter at www.maquire.se until October 8th. We will be starting interviews before this date so please don’t hesitate to forward your application as soon as possible. Please contact Maria Hörnestam +46 763 38 76 46, maria.hornestam@maquire.se if you have any questions.

About Integrum

Integrum AB is a world leader in this area, and patients are being treated in state-of-the-art clinical facilities spread across the globe. The OPRATM Implant System has been in use since the first treatment in 1990, and today more than 500 patients are using an osseointegrated prosthesis replacing an arm, a leg, or a digit. Integrum is also the only company in the world to have received a PMA (Pre-market Approval) from the FDA, for its products used in the treatment of above-knee amputations. We are in total approx. 25 employees based in Gothenburg, Sweden and in the US.