Director Quality and Regulatory Affairs

Reports to CEO

Location: Gothenburg, Sweden


ABOUT THE ROLE

Integrum AB is 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. The role is part of the Management team.

Integrum is a rapidly expanding medical device company on an exciting and challenging growth journey where your contribution makes a difference. You will work with unique products that change people’s everyday life.

 

Essential Responsibilities

  • Develop and maintain company regulatory strategy
  • Maintain and improve QMS effectiveness and suitability
  • Person responsible for regulatory compliance (MDR 2017/745 – PRRC)
  • Line manager QA/RA team
  • Contributing and supporting in development projects from a Quality and Regulatory Affairs perspective during the entire product life cycle
  • Monitoring new regulatory requirements as well as changes to existing regulations to secure compliance with regulations for medical devices on worldwide basis
  • Secure synergies and optimal resource utilization to support the company’s global strategy
  • Secure regulatory requirements and documentation regarding development, registration, labeling, sales, and distribution
  • Plan and perform regulatory submissions and updates worldwide to achieve market access (e.g. CE-marking, PMA, 510K)
  • Contact and coordination with authorities both nationally and globally, and approval of regulatory documentation
  • Implement and plan projects, organize project teams, communicate with internal and external contacts
  • Authority to release/stop products for sale, approve or reject contract manufacturers and suppliers

Required Background/Education/Skills

  • Solid experience from Regulatory Affairs and has worked in the Life Science industry
  • Relevant university degree in engineering, medical device technology or scientific field
  • Knowledge about the regulatory regulations, especially in Europe and the US
  • Experience from development of strategies, evaluation and compilation of the legislation needed for approval of new products and change matters
  • Ability to translate regulations and standards to the company’s needs and reality
  • Argue for your cause and at the same time be open and humble – with high integrity and ability to see the broader perspective
  • Responsible and solution-oriented with excellent communication skills in both Swedish and English
  • Ability to travel, both domestic and international travels will be required

To be successful in this role you need to be driven, structured and used to deliver results. We are looking for a leader with interpersonal skills, able to combine regulatory and quality requirements with business acumen. Someone that likes challenges and to manage change. If you also have a positive mindset and are a proactive team player, you may be the one we are looking for!

Employment Details

  • Full-time employment, the position is based in Gothenburg
  • Competitive salary commensurate with background and qualifications

ABOUT Integrum

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.

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.

 

Applications

Questions regarding this position: contact CEO María López, at maria.lopez@integrum.se or +46 70 846 10 69

To apply for this position please send your CV and cover letter to maria.lopez@integrum.se, no later than September 3rd, 2021.

Interviews will take place continuously during the process.