Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist is responsible for planning and executing regulatory submissions and ensuring regulatory compliance. The individual combines knowledge of scientific, regulatory and business needs to ensure product development, manufacturing and distribution meets regulatory requirements. The individual is able to work independently with minimal guidance and oversight, support new product development and act as a decision-maker on regulatory issues while ensuring deadlines are met.

Responsibilities

• Provide regulatory strategy and guidance on medical device throughout the product development lifecycle, including clinical validation, analysis for stand-alone and clinical performance; AI/ML-enabled devices and SaMD products
• Review and approve R&D, quality and clinical documentation for submission

• Partner with cross functional teams to define scope and innovative regulatory strategy for design and development activities
• Assist with product labeling and review for compliance
• Keep abreast with FDA and international guidance documents and regulations

• Contribute to developing policies, processes, and SOPs necessary to support regulatory compliance including identification of opportunities for improved efficiencies within processes
• Actively participate in problem-solving discussions and recommend solutions
• Partner with the cross-functional team to allow for streamlined workflows, timely and relevant submissions, and thoughtful and creative approaches for the BCI space
• Experience with device software development
• Ability to manage multiple projects and work in a fast-paced, changing environment

Minimum Qualifications  

• 4-6 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.

Skills and Knowledge  

• 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

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: $110-125k/yr