Добавено на 2 months ago
Regulatory Affairs Specialist
Населено мястоOblast Sofia, Bulgaria
Нивo на позициятаSpecialist
Дата на добавяне2024-06-13
ИндустрияLegal and Compliance
Regulatory Affairs Specialist
For one of our trusted clients - a German manufacturing company - world market leader for medical devices, we are looking to find Global Regulatory Affairs Expert:
Responsibilities:
• Implementation of regulatory requirements in the course of product development projects and changes to existing medical devices (planning of documentation evidence, determination of applicable standards);
• Preparation, compilation, and continuous updating of registration documents and approval dossiers according to country-specific requirements;
• Adaptation and maintenance of market approval dossiers to the requirements of the Medical Device Regulation (MDR);
• Interaction with authorities, certification bodies, cooperation partners, external service providers and international regulatory affairs contacts of medical device approvals;
• Participates in the development of regulatory strategies and the processing of global approvals for medical devices as well as receiving these approvals throughout the product lifecycle.
Requirements:
• Completed technical education in mechatronics, electronics, mechanical engineering, or similar;
• Relevant professional experience (preferably medical device technology company);
• Experience with the approval of medical devices and skills in dealing with authorities;
• Project Management experience;
• Very good written and spoken English skills, German would be an advantage;
• Analytical and solution-oriented thinking and sense for pragmatic solutions
Company offer:
• The unique opportunity to apply your professional expertise in a challenging environment and build up processes from scratch.
• The chance to acquire valuable competencies in the presence of high-quality standards.
• Perspectives for career development and growth within a global company.
• An attractive remuneration package based on your experience and benefits like additional health insurance, Multisport card, and food vouchers.
If you recognize yourself in the description and feel that the position is a good match for your career goals, apply today and send your CV in English!
Only short-listed candidates will be contacted. All applications will be treated in strict confidentiality.
Recruitment license from National Agency of Employment № 1814 from 08.12.2014.
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