Regulatory Affairs Specialist with Hungarian / Turkish
Everyday at Wipro Digital Operations and Platforms is challenging and thought-provoking. What is tested is your drive, enthusiasm and initiative. New ideas are appreciated and innovation is encouraged - if you have a suggestion and a plan to take it forward - you will get all the necessary support to transform it into action.Requirements
• Fluency in English and Turkish or Hungarian
• Must be highly analytical and able to evaluate, analyze, and summarize large volumes of data and technical material efficiently
• Life Sciences background preferred with university degree
• Preferred 1 - 2 years of experience in Regulatory Affairs, Medical Report Writing, or Regulatory Compliance specific to medical device
• Direct experience on pre-submissions and HA interactions desired
• Knowledge of global regulatory requirements for medical devices desired
• Ability to communicate clearly both verbally and in writing
• Excellent organizational and presentation skill & proficient with MS office products
The Regulatory Affairs Specialist assists in managing local medical device complaint submission to Health Authorities & ensuring smooth interactions with all Health Authorities in scope.
Interaction with various local vendors relating source data exchange agreements is also a key aspect of this role. Awareness and knowledge of changing regulatory landscape & effectively disseminating the knowledge to all required is expected as a part of the role.
DUTIES & RESPONSIBILITIES:
• Assist the central team in preparing regulatory submissions for all countries in scope, both local country reports & MedDev
• Fully responsible for all local country submissions & MedDev reports for all countries in scope including cover letters as needed
• Interacts with Health authorities in various enquiries related to device complaints and submissions. Any additional asks from Health Authorities
• Provide internal training on regulatory procedures and guidelines
• Assist in translation and review of the medical content/language within the reports
• Maintain knowledge base of existing and emerging regulations, standards, or guidance documents
• Communicate & interact with various local vendors falling in the purview of contract agreements
• Exercise judgment within defined procedures and practices to determine appropriate regulatory action
• Recommend changes to improve practices and procedures
• Take Inputs on reportable events submissions to Health Authorities from the central team and perform any required translation if needed. Process data onto submissions forms and submit the required reportable complaint / patient safety event to the health authority via web / mail. Understand the Health Authority regulation on the process to submit complaints to the Health Authority.
• Take communication from health authorities and coordinate with the client central team on responses. Translate communications to submit as a response to health authority.
• Provide local training to suppliers on their requirements to report patient safety and product complaints as a commitment to client company policy.
• Coordinate Safety Exchange / contract agreements with local suppliers and with the client contracting & legal team. Translation as required.
• Opportunity to work in a fast growing company and in a multinational environment
• Opportunity to grow in the organization and build a successful career path
• Relocation assistance
• Access to a variety of benefits available through a flexible package that can be customized depending on each employees’ needs
• Personal and professional development through a variety of training programs (hard/soft skills)