Biological safety and material specialist

About the position
We are looking for a Biological safety and material specialist to join our team!

This is an opportunity to contribute with your experiences and develop your skills in a value driven company with extraordinary products. Come and join a global emerging leader in orthobiologics with a vision to optimize bone biology for the treatment of bone disorders. Together with bright colleagues at BONESUPPORT, you will as a Biological safety and material specialist make a difference in restoring health to improve the quality of life for patients with bone disorders.

The Biological safety and material specialist will lead and support R&D and product lifecycle management activities in the field of synthetic bone graft substitute (class III implant device/drug combination products).
The Biological safety and material specialist will work together with other scientists and engineers to design, develop, manufacture and test medical devices in a regulated medical device product life-cycle environment.

Responsibilities
• In collaboration with external partners, develop and manage biological safety risk assessments, author, review and approve bio-compatibility test plans, protocols, and reports in accordance with ISO 10993 and FDA Guidance.
• Manage external bio-compatibility testing service providers and coordinate testing at external labs.
• Participate in new product development and product life-cycle management activities.
• Manage relevant maintenance services.
• Review and perform gap analysis and impact assessment of external biological safety standards and regulatory requirements.
• Request, review, and manage database of material specification and safety documents from suppliers.
• Be responsible for updating and maintaining materials & biological safety SOPs.
• Develop and maintain design control documentation.
• Lead and document risk management.

Your profile
• B.Sc. or higher in chemistry, toxicology, biology, or related science field.
• Experience in biological evaluation.
• Experience in medical device design, development and product lifecycle management including design control.
• Experience in applying relevant global standards and regulations, specifically the ISO 10993 family, MDR and FDA guidelines.
• Experience in managing external biocompatibility testing service providers.
• Material knowledge.
• Experience from R&D, product maintenance and lifecycle management.
• Experience in working with Medical Device Risk Management, e.g. ISO 14971, CAPA, Complaint Management, and Nonconformance Reporting.
• Strong technical writing skills as well as good presentation and communication skills

It is a merit if you have:
• Knowledge and experience in class III implant.
• Sterilization processes knowledge.
• Manufacturing processes knowledge.
• Experience of combination (drug/device) medical devices

As a person, you have an analytical approach and understand that working as a team is the key to success.
About the organisation

About the organisation
At BONESUPPORT you will be working together with skilled, dedicated and really nice people who enjoy working in a fast growing and innovative organization. We offer a dynamic and stimulating workplace and strive for generating great teamwork, innovation, passion, and performance. We believe in our journey and take pride in what we do!
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 CERAMENT. The company is based in Lund, Sweden, and the net sales amounted to SEK 213 million in 2021. Please visit www.bonesupport.com for more information.
BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB.

QRIOS Life Science & Engineering is supporting BONESUPPORT on this recruitment. QRIOS is a recruitment and consulting company that is strongly inspired by those who never stop looking for new solutions. As we say, QRIOS MINDS GO FURTHER
We are interviewing candidates on a continuous basis and welcome your application today.