English
Business summary
Inossia has invented and patented the Inossia® Cement Softener to make bone cements softer and better adapted to brittle bone. The soft bone cement can be used both to treat fractures in the spine and to treat painful degenerated discs.
Problem
Osteoporosis affects 50% of all women and 25% of all men over the age of 50 years. Every year, 600 000 bone cement injections are performed in the world to treat osteoporotic fractures in the spine. Unfortunately, up to 40% of all treated patients come back with new fractures within 3 months due to the hard and stiff material of the bone cement.
A second indication is degenerated discs where 400 million patients globally live with daily pain and disability but only 1% gets surgical treatment due to the high complication risk.
Solution – The Technology
With the Inossia® Cement Softener added to the bone cement it becomes adapted to the brittle bone and the rate of new fractures may significantly decrease (<75%). It will provide a better and more reliable treatment with less pain, more satisfied surgeons and patients and save money for the healthcare. For disc patients, the surgical intervention with injecting a soft cement in the disc is minimally invasive and suitable for elderly patients. It offers a possibility for the big majority of patients which today are treated only with painkillers and develop chronic pain for the rest of their lives.
The Inossia® Cement Softener originates from extensive research at Uppsala University led by prof. Cecilia Persson. The technology has received grants through several programs including the EIC Accelerator Project SMART-SOFT, EIT Health Innovation Project SOFTBONE and a handful of Vinnova projects. It has also been awarded The Investors’ Choice at Connect Uppsala, Bona Postulata and the Peter Egardt award. Currently a large randomized controlled clinical trial is on-going at 9 hospitals in Spain, Poland, Germany and Canada.
Further information about the company can be found on: http://www.inossia.com
Head of QA/RA
PeakSearch is recruiting a Head of QA/RA to Inossia AB, a spin-off company from Uppsala University. Inossia is in a very exciting and stimulating phase going from a research and developing company preparing for the product launch of the first soft cement containing Inossia® Cement Softener, for improved treatment of spinal fractures in osteoporotic patients.
Inossia is looking for a highly motivated person with experience from a similar role. The Head of QA/RA shall ensure promotion and awareness of regulatory and customer requirements within the company.
We are looking for a person with the ability to work both operational with day-to-day activities and strategic by having a comprehensive view of the company. As the company is small, you must have a “can do” attitude and be comfortable in situations where you are “hands-on”.
The Head of QA/RA will be a member of the management team, reporting to the CEO for Inossia. The role is a permanent contract full-time and you will be based at the office in Stockholm.
Responsibilities and tasks
• Communicate with Certification body and Competent Authorities
• Overall responsibility for development, implementation and maintenance of the Quality Management System
• Report the status and performance of the QMS (including any need for improvements) to the management team
• Respond regarding matters related to the QMS and regulatory related questions
• Issue, review, approve and/or withdraw SOP of processes and SOPs within QMS
• Manage internal and external audits, issue audit program and handle potential nonconformities from audits
Profile
Inossia now expand their management team with a dedicated Head of QA/RA. We are looking for a person with a strong desire to join a small company and work in a fast-paced environment with freedom and flexibility, as well as high expectations.
You need to be flexible and result oriented, and willing to work in a dynamic environment while managing multiple priorities. It is important to have strong communication skills, with the ability to communicate clearly and effectively both inside and outside the organization. We are looking for an ambitious person with a personal drive to take responsibility, and with the ability to work both independently and together with others to deliver results.
Qualifications and experiences
• Relevant University Degree
• Experience from a similar role within QA/RA in a Medical Device company
• Solid experience from the Medical Device industry, and with ISO 13485 working with class lll or class llb Medical Devices
• Experience from CE marking and FDA-processes
• Excellent communication skills in English. Fluent in Swedish. Other language skills are advantageous
Competencies
• Drive and result orientation
• Self-reliable with ability to prioritize tasks
• Trustworthy and credible
• Flexible, adaptable and pragmatic
• Networking skills
• Excellent intercultural skills
Opportunities with the role
• The possibility to work for a successful, small, growing, and innovative company and work in a fast-paced environment with freedom and flexibility, as well as high expectations
• Work for improved treatment of spinal fractures in osteoporotic patients
• Become a leading key strategic player within Inossia with the opportunity to influence the strategy, way of working, company development and key decisions, and to contribute to the company´s future growth and development
• To work in a small company with a dynamic culture, freedom of action, a nice atmosphere and collaborative environment
• The company is in a very exciting and stimulating phase going from a research- and developing company, preparing for the product launch of the first soft cement containing Inossia® Cement Softener, for improved treatment of spinal fractures in osteoporotic patients
• Be a member in the management team
• Work in values-based company, deeply rooted in science and innovation to transform new ideas and discoveries
• Be part of a very competent and experienced team with high energy, all very committed to develop the company and the technology
• Work in a company with short decision paths and with a high level of personal responsibility
Contact
For more information and questions about the position, please contact Marta Frick Senior Recruitment Consultant at PeakSearch.
Contact details:
marta.frick@peaksearch.se Tel: 070-386 89 69