**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._
**About Philips**
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
- Learn more about our business **here**.**:
- Discover our rich and exciting history **here**.**:
- Learn more about our purpose **here**.