Regulatory Affairs Manager (m/f)

REFERENZNUMMER:

332689/10

IHRE AUFGABEN:

-Development of multi-country regulatory strategy and update strategy based upon regulatory changes
-Determine submission and approval requirements
-Compile, prepare, review and submit regulatory submission to authorities
-Monitor applications under regulatory review
-Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
-Negotiate and interact with regulatory authorities during the development and review process
-Oversee processes with regard to maintaining annual licenses, registrations, listings and patent information
-Labelling content creation and review
-Submission Review
-Country specific regulatory support

IHRE QUALIFIKATIONEN:

-Experience in a regulated industry (e.g., medical devices, combination products, pharmaceuticals)
-Regulatory Knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents
-Knowledge of principles and requirements of applicable product laws
-Knowledge regarding submission/registration types and requirements
-Knowledge regarding international treaties and regional, national, local and territorial trade requirements, agreements and considerations
-Knowledge of domestic and international regulatory guidelines, policies and regulations
-Knowledge of ethical guidelines of the regulatory profession, clinical research and regulatory process
-Specific medical device experience, particularly with Class I and Class II software and/or hardware developed devices, as well as single use, sterile disposables are of advantage

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager