Director of Regulatory Affairs
Director of Regulatory Affairs
The position will be responsible for the development and implementation of regulatory strategy as well as regulatory oversight of company projects. This person will interact with outside regulatory agencies and trade associations and act as an advisor to senior management in regard to planning, evaluation, and recommending the regulatory strategy. He/she will be responsible for all regulatory agency relations including preparation, submission, and follow-up interactions with any/all agencies, including the FDA. Bachelor's degree and experience with aerosol delivery and 505(b)(2) required. Salary and benefits package commensurate with experience.
Top Reasons to Work for Us
- Competitive Salary
- The company pays 100% of health insurance
- Stock option grants
- Work from home
- Help build life-changing technology
Must-Have Skills:
- Experience preparing 505 (b)(2) submissions
- Successful track record of 505(b)(2) submissions for devices containing software components
- Ability to work across organizational levels, able to effectively negotiate and influence, results-focused
- Excellent verbal and written communication skills, ability to partner with others
- Proven cross-functional leadership skills, ability to prioritize and adapt to change in a startup environment
- Self-motivated creative problem solver and can deal with ambiguity and declare a path forward to achieve results
- Strong computer skills, with proficiency in word processing, spreadsheet, and presentation software