Principal Regulatory Affairs Specialist

Zywie is seeking a Principal Regulatory Affairs Specialist to play a key role in the company’s Regulatory Affairs function. This is an exciting opportunity for an experienced medical device Regulatory Affairs professional who wants meaningful ownership, visibility with leadership, and the opportunity to help shape the regulatory function as the company continues to grow. Reporting to the Senior Director of Quality & Regulatory Affairs, this individual will be responsible for executing regulatory strategy across product development and commercialization, with a strong focus on FDA submissions and helping establish scalable regulatory processes and infrastructure. As one of the first dedicated Regulatory Affairs professionals within the organization, this person will have the opportunity to make a significant impact on regulatory strategy, product development decisions, and the foundation of the company’s growing regulatory function. Real ownership: You’ll have a meaningful voice in regulatory strategy and product development decisions. Build, don’t just maintain: Help establish the regulatory processes, systems, and infrastructure as Zywie scales. Executive visibility: Work closely with senior leadership and cross-functional teams across Engineering, Clinical, Quality, and Product. High-impact work: Own key FDA submissions and help bring innovative medical device technology to market. Room to grow: This is an opportunity to help shape the future Regulatory Affairs function and potentially build out the team around you. Mission + momentum: Join a growing medical device organization where your regulatory expertise can have a direct, visible impact. Has a strong track record preparing and managing 510(k) submissions, including Traditional, Special, and/or eSTAR Has experience working directly with FDA reviewers and managing the submission process through approval Can develop regulatory strategy while also being willing to roll up their sleeves and execute Has worked closely with Engineering, Clinical, Quality, Software, Human Factors, and Risk Management teams during product development Understands medical device regulations and standards such as 21 CFR 807, QMSR, ISO 13485, ISO 14971, IEC 62304, and IEC 62366 Comfortable operating in a startup or growing medical device environment where processes are still being built Can independently identify regulatory pathways, anticipate challenges, and provide guidance to product development teams Is a strong technical writer and communicator who can confidently interact with both FDA and executive leadership Wants more than a traditional RA execution role and is excited by the opportunity to help build and shape the regulatory function #J-18808-Ljbffr