ApplyPrincipal Regulatory Affairs Specialist
Posted about 2 months agoViewed
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💎 Seniority level: Principal, 6 years
📍 Location: USA
💸 Salary: 125000 - 140000 USD per year
🔍 Industry: Clinical-stage endovascular brain computer interface
🏢 Company: Synchron👥 11-50💰 $75,000,000 Series C about 2 years agoComputerMedicalMarketingMedical DeviceInformation TechnologyManufacturing
🗣️ Languages: English
⏳ Experience: 6 years
🪄 Skills: Project ManagementProduct DevelopmentStrategyCommunication SkillsCollaborationNegotiationAttention to detailDocumentationComplianceCross-functional collaboration
Requirements:
- 6 years of experience in U.S. and global Class II or III medical device regulatory affairs.
- Submissions experience in medical devices, SaMDs, AI/ML-enabled devices, and digital health software.
- Experience in developing complex submissions with strong organization and attention to detail.
- Ability to work independently and across functions with minimal supervision.
- Knowledge of ISO 13485, design controls, IEC 60601, ISO 14708.
- Understanding of quality, clinical, and regulatory processes.
- Strong technical writing, negotiation, and communication skills.
- Experience in supporting audits.
Responsibilities:
- Participate in Product Development teams providing regulatory input.
- Write and compile regulatory submissions such as IDEs, QSubmissions, PMAs.
- Lead regulatory project management and drive submissions to approval.
- Create necessary SOPs and materials for regulatory compliance.
- Advise the team on regulatory requirements for submissions and post-market obligations.
- Contribute expertise to improve workflows and submission processes.
- Educate and train the team on regulatory and quality processes.
- Manage multiple projects in a fast-paced environment.
- Develop relationships with regulatory advisors.
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