Vigilance Specialist
2 tygodni temu
You have a degree in pharmacy, life science, public health, nursing or similar. Preferably, you have Vigilance or Regulatory experience from the medical device or pharma industry.
Furthermore, you:
- Are structured, disciplined and know how to drive a vigilance process forward.
- Have the ability to keep the overview and be decisive even with several cases on-going at once.
- Have knowledge of regulations, standards and guidelines within the medical device area e.g. MDR, ISO 13485, and FDA 21 CFR
- Have strong communication skills and are fluent in English – both verbal and written.
On a personal note you are a true team player with a positive and flexible mindset, who understands how to reach joint goals. You have a proactive mind-set and a constructive attitude to drive results combined with the ability to plan, execute and meet deadlines. You enjoy working with multiple tasks at the same time and are analytical and capable of digesting complex data without losing the overall picture.
Your main task is to be the specialist in handling vigilance cases, including investigating with colleagues in various parts of Coloplast - for example Medical Affairs and Manufacturing Sites, and creating reports to authorities. Furthermore, you will:
- Interact with authorities to fulfill the regulatory requirements related to vigilance for Coloplast products (e.g. reporting of serious incidents and Field Safety Corrective Actions).
- Effectively communicate vigilance regulatory requirements throughout Coloplast.
- Follow worldwide regulatory development of the vigilance framework.
- Interact with stakeholders throughout Coloplast and provide vigilance training for relevant Coloplast departments and subsidiaries.
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Szczecin, zachodniopomorskie, zachodniopomorskie, Polska Coloplast Business Centre Sp z o.o. Pełny etatYour key responsibilities: Your main task is to be the specialist in handling vigilance cases, including investigating with colleagues in various parts of Coloplast - for example Medical Affairs and Manufacturing Sites, and creating reports to authorities. Furthermore, you will: Interact with authorities to fulfill the regulatory requirements related to...
