Preclinical Analyst m/f/d
Location
Hechingen | Germany
Job description
Die Stellenangebotsbeschreibung ist zur Zeit nicht abrufbar. Bitte versuchen Sie es zu einem späteren Zeitpunkt erneut.
It's a good feeling to know you're doing your best with purpose every day. At Artivion, we manufacture high-quality products and solutions for the treatment of aortic diseases. Together with surgeons worldwide, we save lives. In doing so, we rely on the strengths of each and every employee. Your strength counts, too: As an important link in the chain, you make a contribution to saving lives together with us. Contribute your strengths and let us grow together.
We are hiring a
Preclinical Analyst m/f/d
Your strength:
- Bachelor's or Master's degree in Medical Technology, Biomedical Engineering, Material Science, or a closely related scientific discipline
- Work experience in preclinical research at CRO or medical device manufacturer is an advantage
- Experience with FDA-, ISO-, GMP- and design control regulations
- Working knowledge of relevant sections of EU MDR and Standards (i.e., ISO 10993 and European GLP regulations) pertaining to medical devices in general and more specifically, biocompatibility regulations / standards and toxicology assessments
- Formal biological safety training in ISO 10993 series preferred
- Proficient at project management, with the ability and proven track record to plan, manage and develop multiple projects
- Foundational knowledge to identify and interpret Regulatory / Legal documents and determine the required compliance activities
- Ability to work with team members and other departments, as well as external customers, vendors, consultants and regulatory authorities
- Good spoken and written English skills
Your contribution:
- Supporting the preclinical program for all products manufactured and in the pipeline at the Artivion Hechingen facility
- Maintaining biological safety records supporting approvals for commercially launched products
- Collecting biological safety data to advance new product development
- Management and development of timelines for all preclinical deliverables
- Participation in budget planning for preclinical deliverables
- Coordination of resources, project plans and testing within development projects
- Supervision and participation in all phases of preclinical testing
- Creating documentation and coordinating / performing tests for biological safety.
- Ensure clarity of assignment and accountability for critical project objectives
- Providing technical expertise for biological safety of new and existing products.
Our strength:
- An exciting field of activity in a challenging preclinical environment
- An independent area of responsibility
- Active participation in an international team
- Intensive training with a mentoring program
Apply now and join the Artivion team. We look forward to hearing from you! Please send your English application to:
Daniel Weber, j
[email protected] , T: +49 7471 922 353
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen
Job tags
Salary