Principal Regulatory Affairs Specialist

Summary

Join Synchron, a clinical-stage endovascular brain computer interface (BCI) company, as a Principal Regulatory Affairs Specialist. You will play a key role in supporting regulatory strategy development, worldwide product approval submission activities, and ensuring regulatory compliance. This position requires collaboration with various departments to execute regulatory strategies throughout the product lifecycle. Responsibilities include participating in product development teams, writing regulatory submissions, leading regulatory project management, creating SOPs, advising the internal team on regulatory requirements, and contributing to company knowledge. The ideal candidate will possess extensive experience in medical device regulatory affairs, specifically with Class II or III devices, and strong technical writing and communication skills. Synchron offers a hybrid work location in Brooklyn, NY, with remote options.

Requirements

• 6 years of experience in U.S. and global Class II or III medical device regulatory affairs (active implantable device is a plus)
• Submissions experience in medical devices, SaMDs, AI/ML-enabled medical devices, deep learning-enabled devices, and digital health software
• Have experience in developing complex submissions. Strong organization and attention to detail
• Work independently and cross-functionally with minimal supervision
• Proven ability to prioritize, conduct, and manage time to meet project deadlines
• Working knowledge of ISO 13485, design controls, IEC 60601, ISO 14708
• Understands interaction of quality, clinical and regulatory processes
• Strong technical writing skills
• Good negotiation and written/oral communication skills
• Has supported audits

Responsibilities

• Participate in Product Development teams as needed, providing input on regulatory strategies, timelines, and direction
• Review and approve technical documentation
• Write and compile clear and concise regulatory submissions including IDEs, QSubmissions, PMAs etc
• Lead regulatory project management and independently seek out necessary resources to drive submissions to approval
• Create necessary SOPs, work instructions and other materials necessary to support regulatory compliance at all stages of the product life cycle
• Advise the internal team and lead efforts to ensure regulatory requirements are met for initial submissions, responses, supplements and post-market obligations
• Contribute knowledge, expertise and experience to the cross-functional team to allow for streamlined workflows, timely and relevant submissions, and thoughtful and creative approaches for the BCI space
• Contribute to company knowledge base by leading initiatives to educate and train the team on relevant regulatory and quality processes
• Ability to manage multiple projects and work in a fast-paced, changing environment
• Develop productive working relationships with regulatory advisors and consultants

Preferred Qualifications

Preferred Hybrid in Brooklyn, NY; open to remote

Benefits

Salary range: $125,000 - $140,000