Immucor Inc., a global in vitro diagnostics (IVD) company with headquarters in Atlanta, USA, is a company specialized in immunohematology and corresponding automation systems. We distribute a full line of traditional immunohematology reagents and fully automated instruments and data management software to drive efficiency and productivity. Immucor strives to improve the quality of pre-transfusion testing by driving the implementation of automation especially for university hospitals and transfusion centers, blood donation services for hospitals and laboratory physicians. Our history of laboratory automation began in 1998 and since then we have continuously invested in generation systems.
To support our RA/QA team, we are looking for a
Senior Manager Regulatory Compliance (m/f/d)
(e.g. Biologist, Chemist)
About the Job:
- Develop, implement and manage local and international RA/QA systems in respect to the EEA/WW Quality System and applicable standards like ISO 13485, ISO 9001 and IVD regulation together with the Sr. Director RA
- Responsible for Immucor Medizinische Diagnostik GmbH products registrations within the EEA/WW and provide support to international product registration processes within EEA
- Support requirements for change controls and CAPA process including (product and product performance) regulatory impact and reporting requirements to notified bodies and foreign regulatory agencies
- Act as Deputy Person for Regulatory Compliance for technical documentation and the EU declaration of conformity are drawn up and kept up-to date and the postmarket surveillance obligations are complied with in accordance with Regulation (EU) 2017/746 Article 10(9) and Article 78 as well as reporting obligations referred to in Regulation (EU) 2017/746 Articles 82 to 86 are fulfilled
- Act as Authorized Representative PRRC Deputy as described in Qualification and Appointment for Dominion, BioArray, Immucor Inc. and Immucor GTI
Your Profile:
- You have a Bachelor’s degree in biology sciences, chemistry or another related science field
- Ability to apply knowledge of ISO 9001 and ISO 13485, IVDD standards to the job
- Many years of relevant experience in quality assurance
- Excellent proficiency in English (C1) and German – spoken and written, additional languages are beneficial
- Experience in the administration of compliance monitoring and risk management
- Handle a variety of technical instruments, identify potential issues, collect data, establish facts and draw valid conclusions
- Leadership experience
We offer:
- 30 days of annual leave and flexible working hours including home office – opportunities to reconcile work and family life
- Free employee parking directly in front of the office
- Very intensive and professional induction, followed by various further education and training opportunities
- Regular feedback rounds about your personal and professional development
- Familiar atmosphere in an international and diverse team
- Company pension scheme and capital-forming benefits
- Team Events and Corporate Social Responsibility Events
- Green-Car policy – the entire fleet consists of hybrid and electric vehicles
- Dog-friendly office
- Coffee, tea, water free of charge
- Security of an established, successful company
- Immucor was named “Top Employer 2023” in the category Medium-Sized companies