Principal Regulatory Affairs Specialist

Quality & Regulatory        ·      Brooklyn, New York, United States        ·      Full time

About Synchron

Synchron is a clinical-stage endovascular brain computer interface (BCI) company. Since 2012, the company has been developing a BCI platform that avoids the need for open brain surgery by using a minimally-invasive procedure. The Synchron Switch™ BCI received FDA Breakthrough Device Designation in 2020, and is currently in human clinical trials in the US and Australia.

The company recently announced an oversubscribed $75 million Series C financing round led by ARCH Venture Partners, with participation from Gates Frontier, Bezos Expeditions and other top-tier investors. The funds will accelerate product development, facilitate commencement of a pivotal clinical trial, and advance Synchron towards a first-in-class BCI market approval for the treatment of paralysis.

The Synchron Switch™ brain computer interface is implanted in the blood vessel on the surface of the motor cortex of the brain via the jugular vein, through a minimally-invasive endovascular procedure. Once implanted, it is designed to detect and wirelessly transmit motor intent out of the brain, restoring a capability for severely paralyzed patients to control personal devices with hands-free point-and-click. Synchron is a dynamic, multi-disciplinary and rapidly growing team.

Join our mission of developing a first-in-class commercial BCI for more than 100 million people worldwide with upper limb impairment. Help people with previously untreatable conditions regain connection to the world.

Regulatory Affairs Manager

The Principal Regulatory Affairs Specialist is directly responsible for worldwide product approval submission activities and for ensuring regulatory compliance. This person is responsible for implementing policies, procedures, practices, and strategies for Regulatory Affairs. Collaboration with R&D, Marketing, Clinical, Quality, Operations and other required functions is required to execute regulatory strategies from product inception, launch and throughout the product lifecycle. The Principal Regulatory Affairs Specialist takes a hands-on approach to accomplishing results and provides leadership to staff and colleagues.

We are a lean, fast-paced, passionate team pushing the boundaries of what is possible in the neurotech space to dramatically improve quality of life of millions of people globally. We want you to join us.

Responsibilities  

• Foster and maintain relationships with key regulatory agency personnel
• Develop productive working relationships with regulatory advisors and consultants
• Write and compile clear and concise regulatory submissions including IDEs, Q-Submissions, PMAs etc
• Create necessary SOPs, work instructions and other materials necessary to support regulatory compliance at all stages of the product life cycle
• Advise internal team and lead efforts to ensure regulatory requirements are met for initial submissions, responses, supplements and post-market obligations
• Participate on Product Development teams as needed, providing input to regulatory strategies, timelines, and direction. Review and approve technical documentation
• 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
• Build strong collaborative relationships with internal team and seek alignment and consensus to move work forward
• Contribute to company knowledge base by leading initiatives to educate and train the team on regulatory, clinical and quality processes
• Lead regulatory project management and independently seek out necessary resources to drive submissions to approval

Minimum Qualifications  

• Bachelor’s degree and 5+ years of experience in global Class III medical device regulatory affairs (neuro or cardio preferred) with roles showing increasing responsibility
• Must have been the primary project manager for an IDE and have had a significant contribution to a PMA or major PMA supplement for device approval including software

Skills and Knowledge  

• Proven ability to prioritize, conduct, and manage time to meet project deadlines
• Stays current on regulatory requirements/obligations for relevant work area
• Understands interaction of quality, clinical and regulatory processes
• Has supported audits
• Strong negotiation and written/oral communication skills

At Synchron, we value our culture and the way we work together to achieve our goals. You will be among a group of hard-working, fun and caring people who support each other and are passionate about bringing life-changing technologies to people.

Synchron provides equal employment opportunities to all employees and applicants for employment, and prohibits discrimination and harassment of any type without regard to race, ethnicity, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. 

Salary range: $130k – $150k

Location: Brooklyn, NY