Regulatory Affairs Specialist
1 week ago
Job Summary:
iHealth Labs Inc is seeking a highly skilled Sr. Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical devices.
Responsibilities:
- Develop and implement regulatory strategies to ensure compliance with FDA and international regulations.
- Prepare and submit regulatory submissions, including 510(k) and EUA applications.
- Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
- Provide regulatory support for product development, manufacturing, and design changes.
- Conduct regulatory risk assessments and provide recommendations for mitigation.
- Ensure compliance with internal procedures and external regulations and standards.
- Maintain and update quality system procedures and quality records.
Qualifications:
- Bachelor's degree in Science, Engineering, Math, or a medical field.
- Minimum 5 years of experience in medical device Regulatory Affairs.
- Proven ability to manage small projects and demonstrate exceptional organization and analytical skills.
- Strong communication and teamwork skills.
- Bilingual in Mandarin is highly preferred.
Benefits:
- Medical, Dental, Vision, Life Insurance, and 401K.
- Paid Time Off, Federal Holidays, and Leaves.
- Annual Performance-Based Bonus.
Equal Opportunity Statement:
iHealth Labs Inc is committed to diversity in its workforce and is proud to be an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, marital status, pregnancy, sex, gender expression or identity, sexual orientation, citizenship, or any other legally protected class.
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