Post by Jhony & Maxime on Sept 14, 2015 16:28:01 GMT
Job Title
Regulatory Affairs Junior Manager
Company Profile
Fresenius Kabi is a German-based medical device company that focuses on developing nutrition and drugs pumps. Fluid transfer is the group’s main area of expertise. They are looking to expand their regulatory affairs department by bringing on board a junior engineer in RA. This role will be based in Brézins, France.
Job Description
- You update regulatory affairs documentation with every material change realized in hospital maintenance in Europe.
- You update regulatory affairs documentation in regards with latest European standards.
- You manage instruction manual creation and revision.
- You assist senior manager for audit preparation.
Skills, qualifications
Mastery of relevant regulatory: ISO 13485, European directive 93/42/EEC and risk management ISO 14971
Strong knowledge in electronics and fluid mechanics.
IT literacy
Fluent English is required and a second language is an asset (German, Spanish, Chinese or Arabic).
Education
Master’s degree in regulatory affairs of medical devices.
Prior experience in fluid mechanics.
Type of Job
Full time job
Starting date
October 2015
Date of publication/deadline
Publication: 09/14/2015, Deadline: 9/24/2015
Contact
www.fresenius-kabi.fr/carriere/
Regulatory Affairs Junior Manager
Company Profile
Fresenius Kabi is a German-based medical device company that focuses on developing nutrition and drugs pumps. Fluid transfer is the group’s main area of expertise. They are looking to expand their regulatory affairs department by bringing on board a junior engineer in RA. This role will be based in Brézins, France.
Job Description
- You update regulatory affairs documentation with every material change realized in hospital maintenance in Europe.
- You update regulatory affairs documentation in regards with latest European standards.
- You manage instruction manual creation and revision.
- You assist senior manager for audit preparation.
Skills, qualifications
Mastery of relevant regulatory: ISO 13485, European directive 93/42/EEC and risk management ISO 14971
Strong knowledge in electronics and fluid mechanics.
IT literacy
Fluent English is required and a second language is an asset (German, Spanish, Chinese or Arabic).
Education
Master’s degree in regulatory affairs of medical devices.
Prior experience in fluid mechanics.
Type of Job
Full time job
Starting date
October 2015
Date of publication/deadline
Publication: 09/14/2015, Deadline: 9/24/2015
Contact
www.fresenius-kabi.fr/carriere/
