
Medical Device Regulatory Strategist
1 dia atrás
This role is a critical component of our global strategy to ensure compliance with regulatory requirements for software as a medical device products.
We are seeking an experienced Regulatory Affairs Specialist who will play a key part in implementing and executing our regulatory plans for new product introductions and design changes.
The successful candidate will be responsible for developing and maintaining a deep understanding of the competitive market landscape, regulatory/legislative initiatives, and product marketing strategy.
The ideal candidate will have experience in the medical device industry, particularly with ANVISA, EU MDD/MDR, Health Canada, US FDA, and ISO 13485.
A strong communicator with advanced English skills is essential for this role, as they will interact with international teams through meetings and written communications.
A Bachelor's degree in Pharmacy or a related field, or equivalent experience, is preferred. Experience with Software as a Medical Device (SaMD) is highly valued.
In this role, you will be responsible for:
- Developing and implementing regulatory plans for new product introductions and design changes
- Advising stakeholders on regulatory strategy and requirements
- Composing agency submissions and interfacing with international teams
- Participating in Continuous Learning and contributing to Inclusion and Diversity Committees
About this opportunity:
- Meaningful work that improves lives
- Opportunities for career growth and development
- A collaborative and inclusive work environment
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