Compliance and Regulations Manager
3 weeks ago
Job Title: Compliance and Regulations Manager
Company Overview:
iHealth Labs Inc is a pioneer in the digital health industry, dedicated to transforming healthcare through innovative medical devices and technologies.
Job Description:
This role requires a seasoned Compliance and Regulations Manager to oversee the regulatory compliance of our medical devices and ensure that all submissions to the US FDA and international regulatory authorities are accurate and timely.
Key Responsibilities:
- Development and implementation of regulatory strategies for new products and technologies.
- Cross-functional collaboration with Quality, Engineering, Product Management, Marketing, and Sales teams.
- Review and approval of change order packets and provide regulatory impact assessment for changes to medical devices.
Qualifications:
- Master's degree in Life Sciences, Engineering, Math, or a medical field with a focus on technical writing, scientific methodologies, and problem-solving.
- A minimum of 5 years of experience in medical device Regulatory Affairs, showcasing a comprehensive understanding of regulatory frameworks in the US, EU, and China.
- Demonstrated ability to communicate and negotiate with regulators for the least burdensome approaches to pre-market approval/clearance.
Benefits:
$80,000 - $140,000 per year, plus a comprehensive benefits package including medical, dental, vision, life insurance, and 401K.
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