Regulatory Affairs Specialist

Work Location: Sunnyvale, CA
Annual Salary Range: $70,000 – 95,000
Job Type: Full-Time Onsite

Our Company:

Founded in 2010, iHealth is dedicated to empowering people to live healthier lives. The company is a leader in designing and manufacturing consumer-friendly, mobile personal healthcare products connected through the cloud that allows consumers to easily measure, track, and share vital health information with their doctors. With a focus on delivering high-quality and accessible products, iHealth is at the forefront of the digital health revolution.

In 2018, iHealth established the Unified Care program to address the issue of managing chronic diseases. iHealth Care specialists support patients beyond the doctor’s office with chronic conditions via Chronic Care Management (CCM) and Remote Patient Monitoring (RPM) to achieve better health outcomes.

In November 2021, iHealth’s COVID-19 Antigen Rapid Test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over-the-counter sales. Since then, iHealth has emerged as a key supplier of at-home COVID tests to the federal government, state governments, nonprofits, and individual consumers. With its commitment to helping people lead healthier lives, iHealth is poised to continue driving positive change in the healthcare industry.

Position Overview:

We are seeking a highly skilled and detail-oriented Regulatory Associate to join our innovative medical device company. The Regulatory Associate will be a key player in ensuring compliance with FDA regulatory requirements for the development, manufacturing, and marketing of our medical devices. This role involves close collaboration with cross-functional teams to navigate the regulatory landscape, prepare submissions, and contribute to regulatory strategy.

Job Description

Regulatory Submissions:

Prepare and submit regulatory documents to FDA for product registrations, 510(k) submissions, Pre-submission, IDE applications and other regulatory filings.

Regulatory Compliance:

Stay abreast of changes in FDA regulatory requirements related to medical devices.

Conduct regulatory assessments to ensure compliance with applicable standards and regulations.

Interface with FDA to address inquiries and facilitate approvals.

Quality Management:

Collaborate with Quality Assurance to ensure that regulatory requirements are integrated into the quality management system.

Support internal and external audits, providing regulatory documentation as needed.

Documentation and Record Keeping:

Maintain organized and up-to-date regulatory files and documentation.

Contribute to the development and maintenance of the regulatory documentation system.

Cross-Functional Collaboration:

Work closely with R&D, Clinical Affairs, Quality, and other departments to gather information and ensure alignment with regulatory requirements.

Provide regulatory guidance to product development teams.

Qualifications:

• Bachelor’s degree in a relevant scientific or regulatory field (master’s degree preferred).
• At least 2 years of experience in regulatory affairs within the medical device industry.
• In-depth knowledge of FDA regulations for medical devices.
• Experience with 510(k) submissions, Pre-submission, and IDE applications.
• Strong project management skills with the ability to manage multiple tasks simultaneously.
• Excellent written and verbal communication skills.
• Detail-oriented with a commitment to accuracy.

Preferred Qualifications:

• Regulatory Affairs Certification (RAC) for medical devices.
• Familiarity with 21 CFR 820 and other relevant quality standards.
• Experience with IVD and software as a medical device (SaMD) regulatory requirement.
• Knowledge of emerging trends and developments in the medical device regulatory landscape.
• Bilingual in Mandarin is a plus.

Benefits:

• Medical, Dental, Vision, Life Insurance, and 401K
• Paid Time Off, Federal Holidays, and Leaves
• Annual Performance-Based Bonus

Learn more here