Medical Device Regulatory Specialist
Há 2 dias
This is a Regulatory Affairs role within a global regulatory team, requiring close collaboration with other business areas, including quality assurance, privacy, and security in a fast-paced dynamic software environment.
Key Responsibilities:- Provide leadership and project management for regulatory deliverables as directed by the manager.
- Develop regulatory plans for new product introductions and updates.
- Advise product design teams on regulatory strategies and requirements for updated and/or new products.
- Contribute to developing, modifying, and executing company regulatory policies that impact immediate operations.
- Facilitate communication and best practices sharing.
To succeed in this role, you should possess:
- A bachelor's degree in Pharmacy or a science-related field.
- Advanced English language proficiency.
- Experience in the medical device industry (EU MDD/MDR, Health Canada, China, US FDA, etc.).
- Proficient knowledge of domestic and international standards.
- Ability to manage multiple tasks and perform with accuracy and attention to detail.
Desirable skills include experience with Design Controls and familiarity with medical device regulations (EU MDR, 21CFR/FDA, etc.) and other global laws, regulations, and standards.
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