Senior Biosafety Specialist (2607)

Senior Biosafety Specialist

Are you passionate about biosafety and regulatory compliance in the medical device industry? Do you have profound expertise in biocompatibility and toxicology? And do you want to be a part of the Biosafety & Chemical Compliance team within New Business 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 2nd 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 focus area
This is an exciting opportunity to join our team as a Biosafety Specialist, where you will play a critical role in ensuring the safety and compliance of innovative medical devices, including Class III absorbable devices.

As a Biosafety specialist, you will be an important member of our Biosafety & Chemical Compliance team, which is part of the larger New Business Development area consisting of +50 professionals working with both early-, and late-stage development as well as Life cycle management of medical devices and combination products. As a Biosafety Specialist, you will lead biocompatibility and toxicology activities for medical devices and combination products, ensuring compliance with international regulatory requirements. Your expertise will support the development, approval, and lifecycle management of our high-performing devices in the global market landscape.

You will be a valuable asset in to increase our understanding of requirements for biological evaluation in specific areas such as Asian-Pacific (Taiwan, China, Soth Korea and Japan), and you will engage proactively in the implementation of improvement initiatives relating to strengthening our market expansion efforts.

Your primary stakeholders will be Biosafety specialist and chemical compliance/characterisation specialist within the department as well as you will be working with externally stakeholders and key stakeholders from other departments. It is important that you thrive working in project teams and have a strong understanding of biological evaluation of medical devices.

Your role
In the role as our new Biosafety specialist, your primary tasks will be to:

• You will oversee and monitor biocompatibility studies conducted in collaboration with external contract laboratories (study monitor role).
• Conduct and interpret biocompatibility studies following regulatory standards, including ISO 10993-serie, FDA Biocompatibility guidance, GB/T 16886 series standard.

• Partner with cross-functional teams to provide expert input on material selection, product development, and regulatory input for global submissions, ensuring compliance with international standards and specific market requirements (e.g., China, Taiwan, South Korea, Japan)
• Review and approve protocols, study plans, and reports, ensuring compliance with relevant standards.
• Review and assess toxicological risk assessments for chemical constituents, materials and device components.
• Develop and execute biocompatibility evaluation strategies and biological evaluation reports in alignment with ISO 10993-1 and the broader ISO 10993 series.
• Stay updated on advancements in biocompatibility methodologies and regulatory updates to maintain cutting-edge expertise.

About you
You have a natural flair taking on responsibility, and you have a profound knowledge and experience with biological evaluation of medical devices and combination products, including hands on experience with biocompatibility studies and toxicological risk assessments. Your entry to this job requires an advanced degree in human biology, pharmaceutical science, Toxicology, Biomedical Science, or a related field (Master’s or Ph.D. preferred).

We are looking for a candidate that would like to work in a collaborative self-managing team environment, who enjoy a supportive environment that values professional growth and team success, and who meet (some of) the below requirements:

• Self-driven and outgoing with a positive, can-do attitude.
• The ability to work independent and thoroughly, with a high-quality mindset.
• Excellent problem-solving skills, attention to detail, and ability to manage multiple projects.
• Proven track record and hands-on experience with biological evaluation and biocompatibility testing of medical devices.
• Excellent communication skills, both written and verbal, English, and possible Danish.
• Experience with GMP/GDP in the pharmaceutical or medical device industry is an advantage.
• A profound understanding of GLP requirements and experience in medical and technical writing
• Experience working with Class III medical devices is highly desirable, especially absorbable devices.
• Familiarity with regulatory requirements and hands on experience with key global markets, such as China, Taiwan, South Korea, and Japan, is a clear advantage.

Don’t meet every single requirement? If you are excited about this role, but you cannot meet all requirements, we encourage you to apply for the role anyway. You may be just the right candidate for this role.

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 hemostatic 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?