Junior Regulatory Affairs Specialist:
Supports all regulatory activities on country level necessary to receive approval for medical devices
Assists in the submission of licenses and authorizations for medical devices
Researches and collects information and data to support periodic reports to regulatory agencies
Reviews product labeling to ensure regulatory compliance
Responds to product information requests
Provides Regulatory Affairs support during internal and external audits
May be responsible for other activities such as filing, copying and faxing as needed
Maintains regulatory tracking database, including data entry, updates, and retrieval
Participates in projects related to approved portfolio as required by franchise RA team and EMEA team
Is responsible for various approvals in the Systems linked to job duties
Performs other work-related duties as assigned by supervisor
Expectation:
Regulatory Affairs experience is an advantage
At minimum Bachelors degree or equivalent medical, technical, legal education advantage
Excellent communication skills
Fluent in English
Advanced knowledge of MS Office and data processing applications
Excellent interpersonal skills
Advanced organizational skills and attention to details
Ability to understand cross-enterprise data flow and systems
Strong analytical and organizational skills
Precise planning and execution to achieve accurate and timely results
Please note only successful shortlisted candidates will be contacted