PANDA INTERNATIONAL is a specialist recruitment agency dedicated to placing high-level candidates in freelance and temporary roles within the Pharmaceutical, Medical Device, Biotech and Food sectors across Europe. By working closely with candidates and companies in meeting challenging business demands, the Panda team has developed an extensive client base consisting of the world’s leading Life Sciences organizations.
For a Medical Device client in Overijssel, The Netherlands, we are looking for a Regulatory Affairs (RA) Manager. You’re responsible for the regulatory affairs and the quality processes in a multidisciplinary environment.
Responsible for the RA and QA processes
Supervision of licensing of and facilitation of third party licensing, like distributors
Stay in contact with all notified bodies
Create and support of RA strategies of existing products
Work follow clinical requirements
(Regulatory) data management
RA and QA team management
Develop and implement strategies for maintaining a compliant quality management system
Master degree in engineering or other related field
Medical Devices experience
5+ years Regulatory and Quality Assurance experience
Good knowledge of EC Directive 93/42/EEC (MDD). EC Directive 98/79/EC (IVDD) knowledge is a plus
Experience with ISO 13485
Hands-on, flexible manager
Good computer skills
Project Management and time management experience (working with deadlines)
Fluent in English
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