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Senior Biological Safety Consultant
As a Biological Safety Consultant, you will play a key role in delivering high‑quality, MDR‑compliant biological evaluations that enable our clients to bring safe medical devices to market. You will lead and execute biological safety activities across a variety of device types, building robust strategies in line with ISO 10993-standard series, the EU MDR General Safety and Performance Requirements (GSPR) as well as US FDA requirements.
You will collaborate closely with our internal Clinical Evaluations and QA/RA teams, and support our clients in connection with product development, risk management and post‑market surveillance, to ensure that biological risks are identified, assessed, and controlled. Your ability to develop biological evaluation strategies, interpret scientific data, and convert results into regulatory‑compliant documentation is central to success in this role.
Your work directly contributes to the biological safety and performance of medical devices and strengthens our position as a preferred partner for regulatory and quality support within the medical device industry.
Your responsibilities
- In collaboration with internal teams and clients, plan, coordinate, and author Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs) in line with the ISO 10993-standard series and global regulatory requirements, including EU MDR and US FDA.
- Develop biocompatibility strategies based on device materials, intended purpose, and exposure characteristics, aligned with the ISO 10993‑1 and other relevant standards, as well as applicable regulatory expectations.
- Support clients in coordinating testing with external laboratories, including study design, endpoint selection, and review of test plans and reports.
- Integrate biological safety into risk management (ISO 14971) and technical documentation, including rationales for material selection, manufacturing processes, sterilization methods and residual risks.
- Assist clients during interactions with Notified Bodies on questions related to biological evaluation, test strategies, and evidence gaps.
- Contribute to continuous improvement of internal templates, processes, and best practices.
- Mentor colleagues, share expertise, and support capability‑building within biological safety.
Who you are
You have hands‑on experience with biological evaluations and biocompatibility for medical devices, including planning of evaluation strategies and authoring BEP/BER. You are comfortable interpreting scientific and laboratory data provided by clients or external testing partners and translating this into regulatory‑ready documentation.
You navigate complex regulatory environments with ease. You are analytical, structured, independent, a strong communicator and comfortable working across small/mid/large client organizations. You are service-minded, solutions-oriented and comfortable providing customized assistance for our clients, with their best interest in mind.
- Experience from Notified Body interactions and a range of device classes (I–III, including implantable devices) is advantageous.
You are fluent in English, both spoken and written. You express yourself clearly and professionally in writing.
Swedish is an advantage but not required.
PhD or MSc in a relevant life science field (e.g., biomaterials, biomedical engineering, biochemistry, biology, toxicology), previous work experience in Biological Evaluations and as a consultant is beneficial.
Why GBA Key2Compliance?
Working at GBA Key2Compliance means making a meaningful impact every day. Your expertise directly strengthens our clients’ regulatory and biological safety capabilities and ultimately enhances patient safety. You will be part of a highly skilled team that values collaboration, knowledge‑sharing, and continuous learning.
We offer a supportive, low‑prestige environment with a mix of structure and entrepreneurial spirit — a place where you can grow professionally while contributing to work that truly makes a difference.
Practical information
Workplace: Stockholm, Gothenburg or Lund
Travel: May occur occasionally depending on client needs
Hybrid work: Possible depending on operational requirements
If you have questions about the position, please send them to hr.k2c@key2compliance.com