Regulatory Affairs Specialist
3 weeks ago
Job Summary
We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Philips International. In this role, you will be responsible for developing and executing the regulatory strategy for new product development, design changes, and field safety corrections for US, EU, and RoW.
Your Key Responsibilities:
- Develop and execute regulatory strategies for new product development, design changes, and field safety corrections.
- Collaborate with cross-functional teams to create submission contents.
- Communicate new and coming changes, facilitate/assist with interpretation to guide product and business compliance with Regulatory requirements.
- Monitor global regulatory landscapes and support implementation of regulation changes and execute quality plans to minimize business impact.
Requirements:
- Minimum of a bachelor's degree in engineering or a related scientific field.
- Minimum of 5+ years of experience in the medical device industry with regulatory submission experience.
- Proficiency in understanding, interpretation, and application of FDA 21 CFR 820 Quality System Regulation, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations.
- Prior experience supporting/leading regulatory submissions such as 510(k), EU MDR Technical Documentation, and global registrations.
About Philips International
We are a health technology company that believes every human matters. We are committed to improving the lives of others through our innovative products and services.
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