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Regulatory and Compliance Manager

About StemWave At StemWave , we’re not just building non-invasive regenerative products—we’re shaping the future of healthcare technology. Recognized as one of the fastest-growing companies in the world. StemWave isn’t just leading the orthopedic space; we’re setting the standard for non-invasive healing.  Our ambitious goal? To dominate the global healthcare technology industry through innovation, operational excellence, and a relentless drive to improve patient lives by making advanced medical technology accessible globally.  To achieve this, we focus on three pillars:

• World-Class Talent: We only hire the best—experts who thrive in fast-paced environments and bring their A-game daily.
• Unparalleled Product Innovation: Our goal is to release new versions of our products annually, staying ahead of the curve and setting industry benchmarks.
• Global Scalability & Trust: Our unmatched customer experience and scalable operational excellence inspire trust worldwide.

The Opportunity At StemWave , we’re going global. With explosive growth in the U.S. market and ambitious plans to enter the UK, Canada, and other international markets, we need a driven and innovative compliance leader to join our mission. This is more than just a role—it’s a chance to make a real impact on a fast-growing organization. You’ll have the unique opportunity to:

• Lead Global Expansion: Take charge of international market entry, helping us expand into the UK, Canada, and other global markets.
• Accelerate Innovation Pathways: Streamline regulatory approvals to bring new products to market faster, setting new benchmarks for healthcare technology.
• Establish Gold-Standard Compliance: Develop and manage quality and compliance systems that support StemWave’s global growth.
• Scale U.S. Operations: As we continue to grow, ensure our domestic operations remain robust, scalable, and compliant.

If you’re excited about joining a company where innovation meets opportunity, where your work has real impact, and where the sky’s the limit, we want to hear from you.

Day-to-Day Focuses

• Develop and implement regulatory strategies for new and existing products.
• Prepare and submit global product registrations.
• Drive regulatory efforts to align with new regulations (e.g., EU MDR, MDSAP) and requirements, including changes to international standards.
• Review and approve product labeling, promotional materials, and advertising materials to ensure regulatory compliance.
• Interact with regulatory agencies, including FDA and Notified Bodies, to facilitate product approvals and clearances.
• Represent Regulatory Affairs on cross-functional product development and manufacturing engineering teams.
• Guide teams to provide content for US and/or international submissions; participate in design reviews as needed.
• Conduct regular Internal audits to ensure compliance.

Qualifications

• Experience: 6+ years of experience in medical device regulatory affairs. Knowledgeable of FDA regulations and requirements, including quality management systems, 510(k)s. Experience with international regulatory requirements and standards, including MDSAP, EU MDR, and ISO 13485.

• Education: Bachelor’s degree in Science, Engineering, Regulatory Affairs, or another technically related field.

• Skills: Strong organizational and analytical abilities, with the capability to interpret and apply complex regulatory guidelines. 

• Traits: Proactive, detail-oriented, and a collaborative team player with a solutions-focused mindset.

• Commitment: A shared dedication to StemWave’s mission and core values.

• RAC certification is a plus

___________________________________________________________________________ Position Details

• Compensation: $90,000 to $160,0000
• Full-time, 40+ hours/week, in person at our Boston office.

Why StemWave? StemWave is the ideal environment for ambitious professionals who thrive on challenge and innovation. We’re looking for someone ready to grow, lead, and build the systems that will take us to the next level. Your work here will not just be about meeting standards—it will be about setting them.

How to Apply If you're ready to take on an exciting challenge and be a part of StemWave's growth story, we'd love to hear from you. Please send your resume and a cover letter detailing your relevant experience and why you’re the perfect fit for this role to recruitment@stemwave.com.

Join us at StemWave and be part of something extraordinary. Let's revolutionize the future of shockwave therapy together!