Fixed term - Biological Safety Specialist (Remote – EMEA)

NAMSA a été la première entreprise indépendante au monde à se concentrer exclusivement sur la sécurité des dispositifs médicaux. NAMSA a commencé à tester les dispositifs médicaux avant que la Food and Drug Administration (FDA) aux États-Unis ne commence à réglementer ces produits en 1976.

Chez NAMSA, nous façonnons l’industrie du dispositif médical car notre entreprise a joué un rôle clé dans l’élaboration des méthodes d’essai qui régissent désormais notre activité, activité au sein de laquelle nous sommes devenus leader. De plus, nous accompagnons nos clients à chaque étape du cycle de développement des produits.

Venez travailler pour une organisation riche de valeurs :

Une vision :inspirer des solutions novatrices pour l’industrie médicale afin de faire progresser les soins de santé à l’échelle mondiale, d’améliorer la vie des patients et d’accélérer la réussite de nos clients

Une mission : fournir les meilleures solutions de développement de l’industrie médicale à l’échelle mondiale grâce à nos équipes, notre expertise et nos technologies

Des valeurs :

• Agir avec intégrité dans tout ce que nous faisons

• Offrir la meilleure expérience à nos clients

• Développer des talents et fournir une expertise

• Réagir avec agilité et offrir des résultats pertinents

• Encourager la collaboration, la diversité des opinions et des idées

Description du poste :

About the Role

We are seeking a Biological Safety Specialist to support biological safety and biocompatibility evaluations for medical devices throughout their development lifecycle. Inthis fixed term contract role, you will collaborate with internal teams and clients to ensure regulatory compliance and support successful submissions to global health authorities.

Key Responsibilities

• Prepare toxicological risk assessments, biological evaluation plans/reports in accordance with ISO 10993-1, ISO 10993-17, and ISO 14971.
• Evaluate and summarize biocompatibility, toxicology, and material characterization data to ensure compliance with applicable regulatory requirements.
• Conduct biocompatibility gap assessments and provide clear, scientifically sound recommendations.
• Perform and summarize literature reviews in accordance with applicable standards and guidance documents.
• Interpret regulatory requirements, standards, and testing methodologies for clients and project teams.
• Provide technical guidance to laboratory personnel and support investigations of unexpected biological test results.
• Develop project proposals and contribute to client discussions, presentations, and business development activities.
• Collaborate with multidisciplinary teams to ensure project timelines, quality requirements, and client expectations are met.
• Support regulatory submissions to international regulatory agencies.

Qualifications

• Bachelor's degree in Toxicology, Biology, Biomedical Sciences, Biomedical Engineering, Life Sciences, or a related scientific field with at least 5 years of relevant experience; or
• Master's degree or PhD in a related field with at least 2 years of relevant experience.
• Strong knowledge of medical device regulations, biological safety, biocompatibility, and risk management principles.
• Experience with the ISO 10993 series and ISO 14971 standards.
• Ability to assess compliance of biocompatibility and material characterization data against applicable standards and regulations.
• Strong scientific writing skills with the ability to prepare high-quality technical reports and documentation.
• Excellent communication and presentation skills in English.
• Ability to manage multiple projects and work effectively with clients and cross-functional teams.

Preferred Skills :

• Experience supporting regulatory submissions for medical devices.
• Familiarity with medical device international regulatory requirements.
• Strong analytical, problem-solving, and critical-thinking abilities.
• Client-facing consulting experience is a plus.

What We Offer :

• Opportunity to work on innovative medical device projects impacting patient safety worldwide.
• Collaboration with a highly skilled international team of scientific and regulatory experts.
• A flexible and supportive work environment.
• Professional development and career growth opportunities within a global organization.

If you are passionate about medical device safety and want to contribute to bringing safe and effective healthcare technologies to patients worldwide, we encourage you to apply.