Salary Range: $80,000 - $160,000 (commensurate with experience)
Job Type: Full-Time, Onsite
Overview:
A leading provider in the health care and digital health space is seeking a Senior Regulatory Affairs Specialist to join their regulatory team. The company focuses on developing cloud-connected medical devices, personal healthcare solutions, and home-based tests. As a key player in regulatory oversight, you will help ensure product compliance with global regulatory standards, including ISO 13485 and FDA regulations.
Key Responsibilities:
- Collaborate with cross-functional teams, including Quality, Engineering, and Product Management, to support regulatory compliance throughout product development and market introduction.
- Prepare and review regulatory submissions for US FDA and international regulatory bodies.
- Manage regulatory activities for pre- and post-market requirements, including 510(k) submissions, EUA applications, and MDR compliance.
- Provide regulatory assessments for manufacturing and design changes and review change order packets.
- Maintain and update quality system procedures and ensure compliance with ISO 13485 and FDA standards.
- Participate in external and internal audits, supporting product post-market requirements and regulatory actions.
- Conduct risk assessments and provide regulatory intelligence on product advertising and promotional materials.
Qualifications:
- Bachelor's degree in Science, Engineering, or a related technical field.
- Minimum of 5 years of experience in medical device Regulatory Affairs with a deep understanding of regulatory frameworks.
- Proven experience with FDA 510(k) submissions and regulatory strategy development.
- Strong organizational and project management skills, with the ability to work independently.
- Excellent communication and analytical skills, with attention to detail.
- Bilingual in Mandarin preferred but not required.
Benefits:
- Medical, Dental, Vision, Life Insurance, and 401K
- Paid Time Off, Federal Holidays, and Leaves
- Annual performance-based bonus