Biosafety and Sterilisation Specialist

Biosafety and Sterilisation Specialist
UNEEG Medical / Fuldtid

Slået op: 20.12.2024

About UNEEG Medical
UNEEG medical A/S is a dynamic and pioneering company in the field of medical technology. The company is committed to improving the quality of life for epilepsy patients through innovative solutions that revolutionize epilepsy treatment.

UNEEG medical’s mission is to enable continuous measurement and collection of EEG data 24/7, providing patients and healthcare professionals with deeper insights into the brain. These insights can enhance patient care by optimizing the treatment and management of epileptic seizures. UNEEG medical is at the forefront of cognitive technologies for monitoring and analyzing EEG data, with a strong presence in the European market and preparations for expansion into the USA.

With headquarters in Allerød, Denmark, UNEEG medical employs around 70 dedicated professionals across Europe. As part of this family-owned company, you’ll have the opportunity to contribute to the development and marketing of groundbreaking solutions for epilepsy patients while being part of a unique and innovative culture.

About the department
As a Biosafety and Sterilisation Specialist, you will join a small and highly skilled team of specialists in quality assurance, regulatory affairs, and clinical development. The team works closely with suppliers, external partners, and internal stakeholders, ensuring collaboration across disciplines to achieve the highest standards.

You will report to Senior Director QA, RA, and Clinical Development who provides strategic and managerial support while empowering you to utilize your expertise. To further support your role, you’ll have access to external professional advisors, enabling you to make an impact within the organization.

About the role
In this role, you will be responsible for ensuring the safety and compliance of UNEEG medical’s products through comprehensive biological evaluation and sterilization processes. Your work will span the entire product lifecycle, with a focus on biocompatibility, sterilization, and cleaning validation.

Key responsibilities include planning, executing, and documenting chemical and biological tests, preparing critical documentation such as biological evaluation reports and FDA submissions, and overseeing sterilization validation and testing. You will collaborate with cross-functional teams, internal stakeholders, and external partners to deliver solutions that meet stringent global standards.

This position offers an exciting opportunity to leverage your expertise in toxicology, biology, chemistry, or health technology engineering in a dynamic and innovative work environment.

Key responsibilities

• Prepare biological evaluation reports, toxicological risk assessments, biological equivalence reports, FDA submissions, and material compatibility assessments.
• Plan, execute, and document chemical and biological tests for products.
• Develop and maintain sterilization documentation, including annual reporting.
• Plan, execute, and document sterility testing, cleaning processes, and sterilization validation.
• Collaborate with internal teams and external partners, including contract laboratories.
• Stay updated on legislation governing biological safety, chemical compliance, and sterilization for medical devices to ensure regulatory compliance.

Are you ready to join a pioneering company that is transforming epilepsy treatment and improving patient care?

Apply now to become a Biosafety and Sterilisation Specialist at UNEEG medical A/S through Capax, and contribute to developing tomorrow’s medical solutions!
Capax Recruitment is assisting UNEEG Medical in this recruitment. For further information please contact Vjollca Muaremi [email protected].

Segment: IT

Town: Allerød

Region: Hovedstaden