Biosafety Specialist

Humlebæk, DK

Job Family: Quality Assurance

Country/Region: Denmark

Would you like to help develop new products that will improve the lives of people with intimate health care needs?

Join Coloplast and become part of a team of highly skilled Biosafety Specialists who are working within the Coloplast innovation and life cycle management pipelines, playing an important role in ensuring the biological safety of the Coloplast products.

A team of specialists in a global set-up
At our HQ at Humlebæk, you will join the Biosafety & Chemical Compliance Team consisting of 16 colleagues located in Denmark/Sweden and in Poland. Here, you will work with a wide variety of R&D and supply value stream projects spanning the entire portfolio across ostomy, continence, respiratory, urology and wound & skin from MDR class I to III, including sterile products.

“Come and experience a supportive environment where every team member is valued, and mentorship is key, as you join a diverse global team that thrives on shared knowledge to ensure the biological safety of our products across multiple markets.” says Allan Storm Pedersen, Head of Biosafety & Chemical Compliance.

Your activities and responsibilities will be to:

• Ensure knowledge and understanding of regulatory demands in relation to biological safety of medical devices
• Plan and prepare appropriate and compliant biocompatibility documentation for Coloplast products in development projects as well as for products on the market
• Support the business in relation to questions related to toxicology, chemicals and biological safety for end users
• Stay on top of legislation for biological safety and chemical compliance
• Follow QMS procedures and instructions for biological evaluation activities

This role requires for you to:

• Have experience from the medical device industry preferably as a Biosafety Specialist or similar
• Be familiar with ISO 10993, ISO 14385, FDA guidance for biological evaluation of medical devices and MDR
• Have a Master or PhD degree, preferably in toxicology, pharmacy, chemistry, biology or in a relevant engineering discipline
• Speak and write English fluently
• Have outstanding communication and stake-holder management skills
• Be solution oriented with a can-do attitude.
• Have excellent planning skills, and you can work on several tasks at a time.

In this role you will be supported by the entire team as well as by your mentor, and we will make sure you will have a great onboarding experience.

Interested?
If you would like to know more about the position, please call Allan Storm Pedersen, Head of Biosafety and Chemical Compliance on +45 49 11 23 20. We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate is found.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

Visit us on Coloplast.com.

Watch the film.