Regulatory Affairs Specialist (FDA/Medical Device)

• Regulatory Submission Management: Meticulously compile and organize technical documentation for 510(k), PMA, De Novo, and Annual Reports, ensuring zero errors in compliance.
• Structured Reporting: Provide frequent, detailed status updates to management and clients; synthesize complex data into clear, formal business reports.
• Client Liaison: Act as a respectful and professional representative when communicating with government agencies and corporate clients to facilitate product approvals.
• Strategic Research: Conduct exhaustive research on FDA/EPA regulations to support senior consultants in developing market entry roadmaps.
• Team Support: Assist in various administrative and operational tasks to support the team's success, demonstrating a "team-first" mentality.

• Meticulous Attention to Detail: You double-check your work naturally and take pride in accuracy.
• Respect for Protocol: You are comfortable working within established procedures and respect organizational hierarchy and decision-making processes.
• Dedication: You possess a strong work ethic and a willingness to be flexible with your schedule when critical deadlines or client needs arise.
• Professional Etiquette: You maintain a high level of formality and politeness in all written and verbal communications, suitable for interacting with executives and government officials.

• Education: Bachelor's degree in a STEM field (Biology, Chemistry, Bioengineering, etc.) is required.
• Experience: Previous experience in a corporate or research environment; exposure to Medical Device/Pharma industries is a major plus.
• Technical Skills: Advanced proficiency in Microsoft Office (formatting in Word/Excel must be impeccable); ability to digest complex scientific literature.

• Attributes: Punctual, humble, and eager to learn from senior mentors.

The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.