BONESUPPORT (Nasdaq Stockholm: BONEX) develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs. BONESUPPORT’s bone graft substitutes are based on the patented technology platform CREAMENT. The company is conducting several clinical studies to further demonstrate the clinical and health economic benefits its products deliver. The net sales amounted to SEK 591 million in 2023. Bonesupport has around 130 employees and almost half of them are based in Lund at the company headquarters.
Would you like to improve the quality of life for patients with bone disorders and be part of a growth journey?
Executive Vice President (EVP) Quality Management and Regulatory Affairs
The role as EVP Quality Management & Regulatory Affairs plays a critical role in ensuring that the global efforts in Quality Management and Regulatory Affairs align with the ongoing growth strategy. With overall responsibility for leading the global QM & RA organization, which consists of 11 individuals including 5 direct reports, one of whom is working as a manager, this role contributes to strategic development and decision-making within the global executive team. The focus is on fostering cross-functional collaboration guided by regulatory and quality management principles to drive business development.
As the company is in a growth phase where change is a constant part of daily operations, the ability to both shape long-term strategies and act hands-on to meet immediate needs is essential. This role will also include responsibility for sustainability initiatives, ensuring alignment with environmental, social, and governance (ESG) principles.
The role reports to the CEO and is based at the headquarters in Lund. The key relationships and interfaces in this role is wide, both internal and external and some travel will be required. It will be essential to visit markets to gain the first-hand experience.
Key responsibilities:
Leadership
- Structure, plan and lead the Quality Management & Regulatory Affairs organization.
- Provide strategic guidance and leadership to cross-functional teams, fostering a culture of quality and compliance needed to reach the strategic business targets throughout the organization.
- Provide guidance and mentorship for the organization, cultivating their professional growth and development.
- Set and follow up clear performance expectations and objectives for the team, ensuring alignment with company goals.
- Promote a collaborative and inclusive team culture, encouraging open communication and collaboration.
Regulatory Affairs
- Implement regulatory strategies for new device approvals and market access.
- Ensure RA competencies for global projects.
- Establish and maintain effective relationships with regulatory agencies and notified bodies, ensuring timely submissions and approvals for product registrations and certifications.
- Lead the Regulatory Affairs team in preparing and managing regulatory submissions.
Quality Management
- Establish, maintain, and enhance the QMS to ensure compliance with international standards and requirements.
- Obtain and maintain relevant QMS certifications (e.g., ISO 13485 and MDSAP)
- Ensure effective management of internal and external audits
- Ensure QM competencies for global projects.
- Ensure compliance of BONESUPPORT’s products with regulatory standards.
- Collaborate within BONESUPPORT to establish and manage the Approved Supplier List, including supplier qualification and ongoing evaluation.
- Oversee supplier quality performance.
Sustainability
- Responsibility for developing the sustainability strategy and contributing to the sustainability reporting framework.
About you
We are looking for an experienced leader within Regulatory Affairs and Quality Management with a solid background within medical device or pharmaceutical industry. You have a proven track record of successfully navigating complex regulatory environments in an international context and securing regulatory approvals for medical devices or pharmaceuticals. As an individual, you are driven and a true team player with excellent communication and interpersonal skills, and you enjoy building relationships with others. You have the ability to balance the strategic and overall business perspective with hands-on tactical tasks. You are business minded and solution oriented and as BONESUPPORT is in a growth phase, being structured and able to establish processes for yourself and others to succeed is essential.
Why BONESUPPORT?
At BONESUPPORT you will be working together with skilled, dedicated people who enjoy working in a solidly growing and innovative organization. We offer a dynamic and stimulating workplace striving for teamwork, innovation, passion and performance, which is reflected in impressive employee engagement figures. We believe in our journey and take pride in what we do.
BONESUPPORT has an ambitious strategy and has grown over the last years by market expansion. In 2022 BONESUPPORT received market authorization for US Food and Drug Administration (FDA), for the company's antibiotic eluting product CERAMENT G. Today BONESUPPORT has three products in commercial phase.
BONESUPPORT is a company with a strong culture and puts high focus on leadership and developing the organization to meet the growth strategy. The employees have a high level of knowledge, education, and seniority in their field.
Information and application
We would love to know more about you and your motivation for this job! Please send us your application, CV and cover letter, in English. In this role we are cooperating with Ethel Executive. For more information about this job-opening, please contact Emma Lindén +46763442526 emma@ethelexecutive.se or Louise Brondin Månsson +46763283080 louise@ethelexecutive.se