Principal Regulatory Affairs Specialist

🕒 July 31

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 12%

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Saluda Medical

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Saluda Medical is a pioneering company in the field of neuromodulation, focused on developing innovative platforms to treat chronic neurological conditions. They have created the Evoke® System, powered by their proprietary SmartLoop™ technology, which is designed to measure patients' unique biomarkers and continuously adjust stimulation to maintain therapeutic consistency. Saluda Medical is leading the way in transforming patient care through groundbreaking research and development, and their systems are widely recognized for their advanced capabilities in spinal cord stimulation therapy.

📋 Description

• Provide Regulatory Affairs support for product development, sustaining engineering projects and compliance based activities. • Develop regulatory strategies, prepare global regulatory submissions and partner with cross-functional teams. • Monitor new and changing regulations, assess business impact, and recommend appropriate actions. • Review device labeling, advertising, and promotional materials for compliance with approved submissions and applicable global regulations. • Maintain complete and current regulatory files, product registrations, and supporting documentation. • Prepare for and support communications with regulatory agencies and Notified Bodies regarding pre-submission strategy, regulatory pathway development, testing requirements, clarification and follow-up of submissions under review. • Act as company representative, developing and maintaining positive relationships with device reviewers. • Review and approve design and manufacturing changes, ensuring compliance with applicable regulations. • Support highly technical product lines, including product integrations, sterilization processes and other special projects or strategic initiatives. • Participate actively in regulatory collaborations and alignment with other regulatory specialists supporting product integration efforts.

🎯 Requirements

• Bachelor's degree in a scientific or technical discipline. • Minimum of 7 years' experience in Regulatory Affairs within the medical device industry. • Demonstrated experience with regulatory requirements for implantable or active implantable medical devices. • Demonstrated experience supporting product development and sustaining activities for implantable or active implantable medical devices. • Experience preparing regulatory submissions for medical devices. • Demonstrated experience working within a product development process and design controls. • Strong understanding of FDA regulations, EU MDR, international regulatory frameworks, product lifecycle requirements, labeling review, and regulatory compliance practices. • Experience leading FDA meetings, agency interactions, audits, inspections, and cross-functional regulatory strategy discussions. • Excellent written and verbal communication, technical writing and editing skills.

🏖️ Benefits

• Saluda Medical embraces diversity and equal opportunity. • Committed to building a team representative of a variety of backgrounds, perspectives and skills. • Do the right thing Pioneering – Lead Boldly, Change Lives, Disrupt the Status-Quo Performance – Win together – Deliver with Excellence.