Senior Regulatory Affairs Specialist
3 weeks ago
Senior Regulatory Affairs Specialist
Location: Irvine
About OrthAlign, Inc.:
OrthAlign, Inc. is a leader in Smart Technology, dedicated to transforming the medical device industry with innovative solutions that enhance patient outcomes. Our cutting-edge products are designed to meet the highest standards of quality and regulatory compliance. As a growing company, we are committed to fostering a collaborative and dynamic work environment where our employees can thrive.
About the Role:
We have an immediate opening for a Senior Regulatory Affairs Specialist who will play a pivotal role in ensuring the regulatory compliance of our groundbreaking products. In this role, you will implement regulatory strategies, prepare product submissions, handle license renewals, and provide periodic updates and registrations to regulatory agencies. This position is based in our California Home Office.
Key Responsibilities:
- Represent Regulatory Affairs on R&D product development teams to ensure regulatory requirements are met throughout the product lifecycle.
- Provide guidance on regulatory standards, test methods, and required evidence for US and OUS submissions.
- Prepare and submit regulatory documentation to the FDA, EU, and other agencies.
- Evaluate documents, products, processes, and test methods for regulatory compliance.
- Review labeling and labels to ensure compliance with regulatory standards.
- Conduct regulatory reviews of customer complaints and complete necessary reports.
- Prepare periodic risk assessments, post-market surveillance documentation, and input for clinical evaluation reports.
- Manage license renewals, updates, and registrations in a timely manner.
What You Bring:
- BS/BA degree.
- 4+ years of experience in medical device regulatory affairs, with strong preference for FDA 510(k) Class II orthopedic experience and EU MDR Class I orthopedic devices.
- Deep understanding of FDA and international regulations, guidance, and standards for medical devices.
- High proficiency with MS Office Suite (Word, Excel, PowerPoint).
- Excellent written and verbal communication skills.
- Strong attention to detail and ability to produce high-quality output.
- Ability to work both independently and as part of a collaborative team.
- Strong organizational skills with the ability to prioritize multiple tasks.
- Effective interpersonal skills, including negotiation and relationship management.
- Sound judgment in decision-making and communication with internal and external stakeholders.
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