Job Description

🚀 Now Hiring: Senior Clinical Specialist (Regulatory Affairs)

📍 Location: Memphis, Tennessee | ✈ Travel: Up to 20% | 🕒 Type: Full-Time, Permanent

Are you ready to step into a high-impact role at the intersection of innovation and patient care? We’re looking for a Senior Clinical Specialist (Regulatory Affairs) who’s excited to lead from the front in a fast-paced, startup environment where your voice matters, your expertise drives strategy, and your growth potential is uncapped.

In this pivotal role, you’ll shape and execute both regulatory and clinical strategies to bring life-changing medical technologies to market. You won’t just be part of the process—you’ll be leading it. As our company scales, you’ll have the unique opportunity to grow and lead your own clinical team , playing a key role in shaping our regulatory and clinical affairs functions from the ground up.

🌟 What You'll Be Doing

Clinical Affairs Leadership – 50%

• Own the design, planning, and execution of clinical studies (feasibility, pivotal, PMCF)
• Develop clinical strategies to support U.S. FDA (510(k), PMA, De Novo) and EU MDR submissions
• Collaborate with KOLs, investigators, and cross-functional teams to ensure timelines and objectives are met
• Prepare and submit IDEs to FDA and lead ongoing interactions with the agency
• Analyze clinical data, generate reports, and translate findings into strategic business and regulatory insights
• Support post-market surveillance and contribute clinical expertise to marketing and product development efforts

Regulatory Affairs – 30%

• Lead U.S. regulatory submissions and support international market access strategies
• Advise internal teams (R&D, Quality, Marketing) on global regulatory pathways and product compliance
• Handle establishment registrations, device listings, GMP audits, and complaint handling in line with FDA and global standards
• Interface with FDA, notified bodies, and other regulatory authorities as needed

Veterinary & Operations Support – 20%

• Provide regulatory and clinical oversight for veterinary medical devices and OTC products
• Review labeling, packaging, and promotional materials for compliance
• Support operational initiatives including supply chain and vendor management

🎯 Who You Are

• Experienced: 3–5+ years in regulatory and clinical affairs in the medical device industry
• Educated: Bachelor’s, Master’s, or Ph.D. in Life Sciences, Biomedical Engineering, or a related field
• Experience with 21 CFR Part 803
• Experience with IDE
• Informed: Deep knowledge of GCP, ISO 14155, FDA regulations, and MDR requirements
• Driven: Excited by the pace of a startup and ready to build something from the ground up
• A Leader in the Making: You’ve got the vision and the skills to build and lead a clinical team as the company scales
• Detail-Oriented and Strategic: You’re as comfortable with clinical data as you are in high-level strategy meetings
• Certifications like CCRP or CCRA are a plus!

🌱 Why Join Us?

• Be part of a fast-growing, mission-driven startup changing the medical device landscape
• Take ownership of your work and shape your role as the company evolves
• Work directly with executive leadership and cross-functional teams
• Grow into a leadership role and help build your own team
• Competitive salary, benefits, and flexibility in a collaborative, innovative environment

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