Regulatory Affairs Specialist
2 weeks ago
Join iHealth Labs Inc, a leading provider of cloud-connected medical devices, personal health care devices, and home-based tests, as a Sr. Regulatory Affairs Specialist. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction.
Key Responsibilities:- Perform regulatory pre- and post-market analysis, and implement and maintain an ISO 13485 and FDA compliant Quality Management System.
- Prepare and review regulatory submissions to the US FDA and international regulatory authorities.
- Support government interactions pertaining to medical device registrations and licensing.
- Develop regional regulatory strategy and update strategy based on regulatory changes.
- Provide regulatory support to cross-functional product development and project teams throughout the product lifecycle.
- Bachelor's degree in Science, Engineering, Math, a medical field, or an equivalent educational background.
- Minimum of 5 years of experience in medical device Regulatory Affairs, showcasing a comprehensive understanding of regulatory frameworks.
- Demonstrated ability to manage small projects, displaying exceptional organization, independence, and outcome-driven focus.
- Outstanding analytical and communication skills, paired with a strong sense of teamwork and meticulous attention to detail.
- Medical, Dental, Vision, Life Insurance, and 401K.
- Paid Time Off, Federal Holidays, and Leaves.
- Annual Performance-Based Bonus.
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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