Within the QA/ RA department, you will act as EMEA RA Specialist and will report to QA/ RA Director. The main mission will be to work on the entire RA product lifecycle activities: support to product design/ development projects, product registration, post-market surveillance for oral care, health & beauty products.
By joining our client, you will be able to work on a large variety of category products : Medicinal, Medical Devices, Cosmetic, Foods/ Food supplements, commodity products. Within the QA/RA team, you will also have the opportunity to work in autonomy on the entire RA product lifecycle (from R&D until post-market surveillance).
3 key facts about them:
- A company that has been promoting innovation for over 80 years
- Global presence in over 20 countries worldwide
- QA/RA team : 4 members
Why are they opening this role?
Our client wishes to strengthen their RA team with a new talent with EMEA RA experience in order to support their constant growth.
• Manage RA processes on the overall product life cycle:
o Identify and assess RA requirements with suppliers
o Participate to design & development projects from a RA standpoint
o Manage product registration, regulatory enquiries and framework survey
o Lead RA processes for product identification & traceability
o Drive RA processes for logistic, storage and preservation
o Manage internal and external auditing activities, CAPA, non-conformity
o Lead Post Market Surveillance, Vigilance and Recall to ensure the regulatory standards and requirements are met
• Document and Record Control such as writing and/or reviewing SOP
• Provide regulatory support on internal communication matter
• Support Human Resources with regulatory affairs-related program
• Assess data performance/analysis for regulatory affairs-related processes
• University degree in regulatory affairs and/or in a scientific discipline relevant to human health. RAPS certification for drugs and medical devices is a plus
• Minimum 3 years of RA experience within life science industry, including regulatory support to product design & development projects, product registration and PMS
• Professional RA experience in EMEA in at least 2 of these industries: Medical devices, Medicinal, Health Care, Cosmetic, foods/food supplements, commodity products
• Experience in project management as project team member
• Capacity to easily adapt to different cultures and international environment
• Ability to independently identify compliance risks and escalate when necessary
• Autonomous and problem-solving mindset
• Good command of computer literacy: MS Office
• Fluent in English both written and spoken