Vigilance Specialist
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Humlebæk
Are you keen to work with user safety? Want to work with both internal and external stakeholders around the world? Then join us as we seek a resourceful and proactive Vigilance Specialist in Global Quality & Regulatory Affairs and be part of our mission to make life easier for people with intimate healthcare conditions.
About the department
In Humlebæk, Denmark, you become part of Post Market Surveillance & Quality Processes, a department within Global Quality & Regulatory Affairs consisting of 10 highly skilled specialists. We are an engaged team of 4 Vigilance specialists, 3 Design Control specialists, and 3 Process managers. You will join the Post Market Surveillance team, operating in a dynamic and professionally challenging working environment.
Your new job in Coloplast
Your main responsibilities will be to diligently investigate serious incidents and report to national competent authorities according to applicable regulatory guidelines and timelines. Furthermore, you take the lead in handling safety issues related to the use of our products and deliver vigilance data for registration of products in new markets.
Your key responsibilities
Your main task is to be the specialist in handling vigilance cases, including leading the organization of investigations with colleagues in various parts of Coloplast – for example Medical Affairs and Manufacturing Sites. Furthermore, you will:
Your qualifications
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:
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.
Interested?
At Coloplast, we make sure that you can be you. That is why we encourage applications from suitably qualified and eligible candidates regardless of sex, race, ethnicity, disability, age, sexual orientation, gender reassignment, religion or belief or marital status.
For further information please contact Head of PMS & QP, Lotte Dock Steenstrup, at [email protected] or +45 4911 3254.
Deadline
Please note that we take candidates into the recruitment process continuously until we have found the right candidate.
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with very private and personal medical conditions. Employing more than 12,000 people and with products available in more than 140 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. Curiosity works here.
Visit us on Coloplast.com. Follow us on LinkedIn. Like us on Facebook.
About the department
In Humlebæk, Denmark, you become part of Post Market Surveillance & Quality Processes, a department within Global Quality & Regulatory Affairs consisting of 10 highly skilled specialists. We are an engaged team of 4 Vigilance specialists, 3 Design Control specialists, and 3 Process managers. You will join the Post Market Surveillance team, operating in a dynamic and professionally challenging working environment.
Your new job in Coloplast
Your main responsibilities will be to diligently investigate serious incidents and report to national competent authorities according to applicable regulatory guidelines and timelines. Furthermore, you take the lead in handling safety issues related to the use of our products and deliver vigilance data for registration of products in new markets.
Your key responsibilities
Your main task is to be the specialist in handling vigilance cases, including leading the organization of investigations with colleagues in various parts of Coloplast – for example Medical Affairs and Manufacturing Sites. 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
Your qualifications
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
- You have the ability to keep the overview and be decisive even with several cases on-going at once
- You have strong communication skills and are fluent in English – both verbally and written
- Having knowledge of medical device regulations and standards (e.g. MDR, ISO 13485) or similar knowledge from the drug industry will be a plus
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.
Interested?
At Coloplast, we make sure that you can be you. That is why we encourage applications from suitably qualified and eligible candidates regardless of sex, race, ethnicity, disability, age, sexual orientation, gender reassignment, religion or belief or marital status.
For further information please contact Head of PMS & QP, Lotte Dock Steenstrup, at [email protected] or +45 4911 3254.
Deadline
Please note that we take candidates into the recruitment process continuously until we have found the right candidate.
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with very private and personal medical conditions. Employing more than 12,000 people and with products available in more than 140 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. Curiosity works here.
Visit us on Coloplast.com. Follow us on LinkedIn. Like us on Facebook.
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Humlebæk.
Jobbet er oprettet på vores service den 20.3.2020, 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.
- Produktspecialist
- Humlebæk
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Statistik over udbudte jobs som produktspecialister i Humlebæk
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