Regulatory Affairs Specialist- Irvine
1 month ago
Are you passionate about navigating global regulatory landscapes and ensuring the compliance of life-saving medical devices? We're looking for a skilled Regulatory Affairs Specialist to join a vibrant team in Irvine, CA
This medical device company are pioneering innovative medical solutions that enhance patient care worldwide. Their International Regulatory Affairs team plays a crucial role in shepherding products through the regulatory process, working closely with in-country representatives to secure approvals and clearances.
Pay Rate Range: $44-$49 per hour
Location: Irvine, CA (100% onsite)
Duration: 8 month contract
Key Responsibilities:
- Develop and maintain regulatory submissions for product approvals and clearances, collaborating with overseas affiliates.
- Provide strategic guidance on regulatory pathways and contingency planning for international markets.
- Represent the regulatory function on cross-functional teams, ensuring alignment with global regulations.
- Collaborate with business unit teams to navigate registration requirements, product changes, and process enhancements.
- Additional duties as assigned by leadership.
Requirements:
- Bachelor's degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry).
- 5-7 years of experience in regulatory affairs within the medical device industry.
- Proficiency in Microsoft Office Suite, particularly Excel for data analysis and reporting.
- Strong understanding of international regulatory standards for medical devices, including Class II and/or Class III.
- Experience with regulatory submissions and documentation, including Design History Files.
- Meticulous attention to detail and ability to manage competing priorities in a fast-paced environment.
Please apply with an updated resume to be considered
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