Regulatory Affairs Specialist

About the role

The Regulatory Affairs Specialist (RAS) works to gain successful 510(k) approval by leveraging skills and expertise to anticipate regulatory requirements and integrate compliance into project plans. The RAS streamlines preparation and submissions, ensuring documentation is accurate, complete, organized, and accessible. The role collaborates with other departments to compile information and ensure compliance requirements are met throughout the product lifecycle.

Responsibilities

• Successfully gain 510(k) and NDA approval with the US FDA.
• Represent regulatory affairs and serve as a liaison between regulatory bodies and cross‑functional teams, providing regulatory feedback and guidance throughout the product development cycle.
• Research, develop, and implement regulatory and compliance strategies for new and modified medical devices in accordance with applicable regulatory bodies.
• Prepare and submit applications and reports to applicable regulatory agencies for medical devices.
• Respond to all requests for information from regulatory bodies in a timely and organized manner.
• Maintain a current and working knowledge of regulations applicable to the company.
• Develop and maintain positive, professional relationships with device reviewers through oral and written communications.
• Develop and maintain standard operating procedures, work instructions, and policies to ensure compliance with applicable regulations and standards.
• Compile and communicate regulatory impact assessments and submission approval status reports.
• Support various audits.
• Perform other responsibilities as assigned.

Requirements

• Minimum of 3–5 years of relevant work experience in regulatory affairs, specifically compiling and submitting 510(k) applications.
• Bachelor’s degree in a relevant field preferred.
• Strong knowledge of medical device regulations and standards.
• Experience with regulatory submissions and interactions with regulatory authorities.
• Solid company‑centric ideology and creative problem‑solving skills.
• Ability to balance multiple priorities.
• Core values of honesty and respect.
• Desire to be challenged and thrive in an autonomous work environment.
• LEAN mindset and willingness to be the first person to help.
• Proactive in seeking opportunities to add value.

Benefits

• 401(k) retirement plan
• Health benefits: medical, dental, vision
• Wellness program
• Life insurance
• Corporate‑sponsored events
• Skill‑growth opportunities
• Short‑term disability coverage
• Ability to advance within the organization
• Work with energetic and creative problem solvers
• Mission‑driven environment that values your energy and expertise