Principal Regulatory Affairs Specialist

The Principal Regulatory Affairs Specialist is responsible for supporting regulatory strategy development, worldwide product approval submission activities and for ensuring regulatory compliance. This person is responsible for implementing policies, procedures, and practices for Regulatory Affairs. Collaboration with R&D, Marketing, Clinical, Quality, Operations and other functions is required to execute regulatory strategies from product inception, launch and throughout the product lifecycle.

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

Minimum Qualifications  

• 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: $140,000