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Praca świętokrzyskie  /  Oferty pracy  /  Biosafety and Vigilance Team Leader

Praca: Biosafety and Vigilance Team Leader


Biosafety and Vigilance Team Leader
Miejsce pracy: woj. świętokrzyskie

Coloplast develops products and services that make life easier for people with very personal and private medical conditions. In Coloplast Business Centre we are responsible for global financial operations, orders administration, HR and IT support, marketing & data analysis activities, and many others. If you have the right profile and the right amount of curiosity and ambition you can be a part of this exciting challenge. Curiosity works here!

 

About the department


The Biosafety & Vigilance Team is part of the Global Regulatory Affairs Group within Global Quality and consists of colleagues in Poland and Denmark. Our main responsibilities are to deliver biocompatibility documentation and ensure compliance with regulatory demands – with no compromises on product safety. We do so through literature studies, product testing and assessments according to international standards, which we then evaluate and document in writing.
 

About the job
The job is located in Coloplast Business Centre in Szczecin, Poland. The aim of the role is to lead the team and the communication between CPBC and HQ Biosafety & Vigilance team. Also, to ensure optimal ways of knowledge transfer and sharing between HQ and CPBC teams as well as relevant task split and process setup.
 
Your responsibilities

  • Prioritize and execute daily tasks in alignment with stakeholders within HQ Biosafety & Vigilance teams
  • Understanding of and interpretation of quality data
  • Analyse processes and find possibilities for optimization and improve system usage
  • Ensure high level of performance within assigned teams, monitor results, set and measure KPIs
  • Depending on background ~40-50% of workload will be operational (Biosafety, Chemical Compliance or Vigilance)
  • Ensure proper level of knowledge and competence development within relevant area
  • Can be asked for input, in internal and external audits
  • Participate in development and maintenance of Regulatory procedures and instructions within the company
  • Contribute to regulatory awareness and good documentation practice

 

Requirements 

  • Master’s degree within a relevant scientific field (eg. biochemistry, biology, chemistry, or pharmacology).
  • 2+ years of experience within the biosafety field for medical devices/or other environment
  • 2+ years of leadership experience 
  • Knowledge of biological evaluation and toxicological risk assessment 
  • Knowledge of relevant standards and legislation (for example: ISO13485, Medical Device Directive, FDA-part 820, Health Canada Device regulations, Japanese QMS for Devices) with special focus on regulations for Vigilance (nice to have)
  • Knowledge of directives, standards, and guidelines within the regulatory medical device area
  • Knowledge of chemical legislation within Europe
  • Fluent in both verbal and written English
  • Advanced knowledge in Excel

We Offer

  • No probation period – long-term contract from the start
  • Challenging tasks and growth opportunities in a motivating work environment
  • Gaining experience in an international organization
  • Opportunity to use and develop foreign languages in daily work
  • Fantastic work atmosphere full of respect and partnership
  • Support with relocation, if needed

Thats not all! We have even more for you!

  • Modern workplace
  • No dress code zone
  • Great winter and summer events, and family picnics
  • Delicious coffee and fresh fruits
  • Private medical care
  • Sports card
  • Transportation co-funding
  • Restaurant card
  • Holiday bonus and occasional cards

Deadline


We will take candidates into the recruitment process continuously so do not hesitate to apply on-line via our job portal. We will close the position down once we have found the right candidate.

Please apply by sending your application in English.
If you are curious like we are, and want to know more about our company go to http://www.cpbc.pl

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12.000 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. Follow us on LinkedIn. Like us on Facebook.
By clicking the "Apply" or "Apply Now" button or by sending a recruitment application otherwise to Coloplast Business Centre Sp. z o.o., you agree for processing of your personal data for recruitment purposes in accordance with art. 6 par. 1 point b and f of the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and of the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). You also agree to the processing of personal data included in the application form for future recruitments by Coloplast Business Center Sp. z o.o.
The administrator of personal data is Coloplast Business Center Sp. z o.o . with registered office in Szczecin, ul. Piastów 30, 70-064 Szczecin; contact to the Data Protection Officer: dataprotectionoffice@coloplast.com.
In addition, we would like to inform that:
  • Your personal data will be processed up to six months from the completion of the recruitment process.
  • You have the right to request access to your personal data, its rectification, erasure or limitation of processing and the right to object to processing, as well as the right to data portability.
  • You have the right to withdraw your consent at any time. The above does not affect the lawfulness of processing which was carried out on the basis of your consent before it was withdrawn.
  • You have the right to lodge a complaint with a supervisory authority - the President of the Office for Personal Data Protection.
  • Providing your personal data by yourself is voluntary, but necessary to participate in the recruitment process.
  • Decisions regarding the recruitment and selection process will not be taken in an automated manner.


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