Biosafety Specialist

Biosafety Specialist

Coloplast

Humlebaek, Denmark

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

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Denmark      Medical Devices      On-site      Quality Assurance      Coloplast