Director of Regulatory Affairs

Who Are We?  Powered by technology and compassionate design, Parachute has reimagined the plasma donation experience into one that is easier and friendlier. Using a simple app, our members can book donations and track earnings from the palm of their hand. In using a tech-forward approach, we’re able to offer each member a highly personable and best-in-class experience that’s consistent at each and every visit.  Our vision is to introduce an elevated plasma donation experience to markets with smaller populations that’s grounded in convenience. This model allows us to positively impact the industry supply chain and help patients gain access to the medication they need.  We have grown from 2 to 29 operations in less than three years and plan to continue our rapid expansion. We are looking for people who share in our passion for helping others and are invigorated by the speed at which our start up moves. Come join us as we help the world gain access to more plasma - one donation at a time.  What You'll Do:    As the Director of Regulatory Affairs at Join Parachute, you will be responsible for building and refining regulatory processes for our expanding product portfolio. You’ll play a crucial role in ensuring that our Centers meet all regulatory requirements while allowing for business growth and innovation. You will guide the company in navigating complex regulatory landscapes, from interpreting FDA regulations to developing innovative regulatory strategies.  Lead the creation and implementation of regulatory strategies that align with both the company's business goals and compliance requirements.  Ensure that our growing portfolio of products comply with regulatory standards and evolve with changing regulations. Oversee regulatory risk management to ensure that compliance is maintained without stifling the company’s ability to grow.  Partner with cross-functional teams to provide regulatory guidance.  Oversee and manage communications, including the submission process for regulatory filings, with the FDA and other agencies.  Manage and mentor a team and foster a culture of continuous learning and strategic thinking, and lead by example with innovative solutions for regulatory challenges. Advise on interpretation and application of the Code of Federal Regulations (CFRs) and other relevant regulatory guidelines for our products.  Who You Are:    Experienced Leader: You're a subject matter expert in regulatory affairs with a proven track record in guiding organizations through complex regulatory landscapes. You have a deep understanding of FDA processes and how to align them with business needs. Strategic Thinker and Executor: You’re focused on both the day-to-day regulatory processes and strategic regulatory decisions that align with the company’s long-term goals. You know how to balance regulatory compliance with the need to drive business growth. Creative Problem Solver: You're comfortable navigating ambiguity, making informed decisions in areas with unclear or evolving regulatory frameworks, and finding solutions that allow the business to move forward without compromising compliance.  Collaborative and Communicative: You work effectively with cross-functional teams, helping them understand complex regulatory requirements in a straightforward way. You can communicate clearly with both internal teams and external regulators. Startup Mentality: You’re comfortable in a fast-paced, dynamic environment where you’ll need to be proactive and adaptable. You know how to balance the need for structure with the flexibility that comes with a startup culture. Growth-Oriented: You see the bigger picture and are committed to the company’s success. You want to contribute to a team that is doing something different and impactful, and you're motivated to build something lasting. Benefits Competitive compensation with bonus potential Medical, Dental, and Vision insurance Paid time off Company paid holidays Career growth opportunities