CEO & QARA HEAD SWEDEN, Labquality

Labquality Corporation has recently acquired Swedish QAdvis AB, which specializes in quality management and regulatory affairs services for medical device and in vitro diagnostic device manufacturers. With 25 employees and offices in Stockholm and Lund, QAdvis has a strong position in the Swedish quality and regulatory affairs services market. QAdvis also has broad experience and know-how in medical device software, from risk management and validation to quality assurance. The acquisition aligns with Labquality’s international growth strategy and enables Labquality to enter and grow its business in Sweden. For more information, please visit www.qadvis.com.

This is a new and very exciting opportunity to lead and further grow the QARA business geographically and form a strong and dedicated team based in Sweden and Finland. As CEO and head of QARA you will report to the CEO of Labquality and be part of the management team. In addition, you will be leading the QAdvis team with 25 employees as well as 3 teams based in Finland with a total of 15 employees. The Finnish teams are QA/RA IVD, Digital Health and Consulting, Clinical Trials.

Qualification Requirements

• Extensive experience and understanding regulatory affairs and quality assurance or a related field is mandatory, preferably in the medical device industry.
• Solid experience from working with customer relations and industry network management. Background in sales is preferred.
• Proven experience in executive leadership roles is an advantage, preferably as CEO or in a similar capacity.

Key Tasks

• Provide visionary leadership and strategic guidance to the Quality and Regulatory Affairs (QARA) business unit.
• Lead the organization in further growing the business with existing and new clients and customers. Take active part in customer interaction activities.
• Oversee the meticulous planning, preparation, and execution of regulatory compliance activities in alignment with regulatory requirements and company standards.

Responsibilities and Duties

• Full P&L responsibility
• Develop and execute strategic plans to achieve business objectives and proper growth within the organization.
• Establish and maintain effective communication channels with internal stakeholders, including senior management and functional leaders.
• Ensure unwavering adherence to relevant regulations, standards, and guidelines governing quality assurance and regulatory affairs activities.
• Cultivate an ethos of quality, integrity, and excellence within the quality assurance and regulatory affairs team.
• Report to the CEO of Labquality and be part of the management team.

Please apply through haegercarlsson.com

Questions are answered by:

Rolf Carlsson, +46 (0)70-316 1268, rolf@haegercarlsson.com
Anna Wikman, +46 (0)73-539 3387, anna@haegercarlsson.com