Director of Regulatory Affairs
Position will be responsible for 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 advisor to senior management in regard to planning, evaluation, and recommending 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 Compensation and Salary
- Help build life changing technology
- Rapidly growing company
- Company pays 100% health insurance
- Stock option grants
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.
Responsibilities
- Ensure regulatory submissions meet appropriate standards and content requirements.
- Lead and manage regulatory annual updates and submissions.