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Regulatory Affairs Specialist
4 meses atrás
Job Title:
Regulatory Affairs Specialist
_ Regulatory Affairs Specialist_
- This person will be responsible for assisting in the implementing of the global regulatory strategy for software as a medical device products and roadmaps through understanding of the competitive market landscape, regulatory/legislative initiatives, and product marketing strategy for the products._
Your role:
- _ Regulatory planning for new product introductions and/or design changes from _initial stages of _development/change project_s_ until regulatory approvals with regulatory agencies _worldwide_
- _ Advising _national and _international stakeholders_ (product management, marketing, _R&D,_ quality_ etc.)_ _on regulatory strategy and requirements for _changes_ _and/or new products_ and markets_._
- _ Develop stronger w_ritten, oral_ and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with reduced supervision._
- _ Be _a reference for tactical alignment across teams on regulatory aspects_._
- _ F_rom Continuous Learning to Inclusion and Diversity Committees _and opportunities a career at Philips comes with all sorts of wonderful benefits. Be sure to speak to your recruiter about benefits in your region._
You're the right fit if:
- _ Experience_ in the medical device industry (ANVISA, EU MDD/MDR, Health Canada, US FDA, ISO 13485, etc.)_
- _ Experience with international submissions is _desirable._
- _ Advanced to Fluent English for communication and writing _-_ you_'_ll be interacting with international teams through meetings and written _communications._
- _ Bachelor's degree, preferably in _Pharma_cy_ and / or in a field related to science or equivalent experience in the medical device _industry._
- _ E_xperience with _Software as a Medical Device _(_SaMD)_ is considered a strong differential._
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