Biosafety Specialist
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Søborg
Biosafety Specialist
Do you want to be a part of a Biosafety Team within Product Development in a company with a unique impact on global healthcare? Grab this opportunity to join a rapidly growing company, ready to invest in you. Here you will not only get to impact the production and development of our products; you will also have every opportunity to develop and grow your own skills.
Every 3rd second Ferrosan Medical Devices’ products help surgeons and nurses control bleedings and avoid complications in surgical procedures. We make seconds count in surgical care! And we need you on our team!
Biosafety Specialist
As our new Biosafety Specialist, you will be involved in both development of new Medical Devices and maintenance of our current product portfolio.
Your key tasks will be biological evaluations incl. setting up relevant studies, toxicological support and risk assessments and ensure compliance to standards within biological evaluation. You should be up to date on trends within the field and development within toxicological principles.
You will have a broad interface within the company, where both Regulatory Specialists, Project Engineers, Process Supporters and QA specialists are among your key collaborating partners. Internally in Product Development, you will also have a broad collaboration with our Labelling and Design & development specialists. You will be a part of our biosafety specialist group.
You will join our Product Development department with 14 professionals. We are experienced and diverse in both skill sets and backgrounds, and as a team, we work with dedication to deliver state-of-the-art product documentation.
Product Development is responsible for all product design requirements in both development projects and line extension projects. We are involved in all project phases from idea to production. We generate data that proves that the design, functionality, efficacy, and safety meet specifications and contribute to ensuring our product documentation complies with regulatory requirements.
Your role - You
- Plan biological evaluations incl. communication with Contract Research Organisation in projects.
- Perform toxicological risk assessments and reporting on biological studies.
- Produce technical documentation such as biological evaluations and statements to support submissions within product development.
- Provide toxicological support for production e.g., for deviations and cleaning validations.
- Evaluate safety and effectiveness including toxicological risks in changes to product or production
About you
Ideally, you have a strong background in biology and an interest for developing your skills further within biosafety and toxicology. You are positive and see solutions to the identified problems. You can relate to the complexity in our absorbable gelatine-based drug device products, and you thrive applying your knowledge across a wide range of tasks. Other than that, you also have
- Relevant work experience from a similar role, however not necessarily in biosafety or toxicology, but within medical device/MedTech, pharma, medico.
- A MSc or PhD within a relevant science, e.g., biochemistry, pharmacology, biomedicine, or human biology
- Experience with regulatory demands, including the ISO-10993 or a desire to learn fast.
- Good understanding of GMP and cross organizational collaboration with e.g., RA and QA.
- Experience with QSAR, chemical characterization and coordination of in vitro and in vivo test activities at contract laboratories, or the desire to learn fast.
- You are up to date with standards within biological evaluation of medical devices (ISO 10993 series and others)
We offer a truly purpose driven workplace where you can have real impact
We offer a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to our new colleagues. We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.
We offer an inclusive workplace with the opportunity to have real impact and a development curve, that you can steepen in the pace, that is suitable to you. You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words. And we take pride in having fun 😊
Some of the facts and a little piece of history
Ferrosan Medical Devices develops and produces a portfolio of medical devices used in surgical care. Our portfolio consists of various haemostatic products to minimize bleeding challenges in surgery and electromechanical medical devices to perform breast biopsies. We are an international company with products registered in more than 100 countries. Our products are marketed in collaboration with global MedTech partners. New ideas are developed and matured from the first thought to finished implementation in production. And we manage the business with an uncompromising focus on quality based on current GMP requirements.
Want to join our team?
Send your application along with your CV as soon as possible. We will process the applications as we receive them.
Questions? Please do not hesitate to contact Anne Borgen, Managing Partner, Peoplement, on +4561690101
We look forward to hearing from you.
Read more about us here
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 2.12.2022, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Søborg
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