Principal Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Saluda Medical is a commercial-stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed-loop neuromodulation platform. The company's proprietary technology senses and measures neural responses to stimulation and automatically adjusts therapy based on real-time neurophysiological feedback.

Saluda Medical's first product, the Evoke® System, is designed to deliver known, consistent, and personalized spinal cord stimulation therapy by objectively measuring neural responses and maintaining therapy within a prescribed therapeutic window. Saluda Medical is headquartered in Minneapolis, Minnesota.

At Saluda, we challenge boundaries. We innovate and think beyond the conventional. Our focus is to revolutionize the standard of care in neuromodulation to positively impact patient's lives.

As a Senior Regulatory Affairs Specialist, you will provide Regulatory Affairs support for product development, sustaining engineering projects and compliance based activities. In this role, you will develop regulatory strategies, prepare global regulatory submissions and partner with cross-functional teams to help ensure products meet regulatory requirements throughout the product lifecycle.

Responsibilities:

• Provide guidance to cross-functional partners and junior regulatory affairs staff.
• 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 through oral and written communications.
• Develop and implement regulatory strategies for new and modified products.
• Act as the Regulatory Affairs lead on product integration workstreams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle while coordinating team inputs for regulatory submissions.
• Review and approve design and manufacturing changes, ensuring compliance with applicable regulations.
• Prepare and submit global regulatory applications.
• 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.

Qualifications:

• 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.

Preferred Qualifications:

• Experience preparing a variety of regulatory submissions, including PMAs and 510(k)s for implantable or active implantable medical devices.
• Demonstrated knowledge of regulations applicable to the conduct of clinical trials.
• Demonstrated experience collaborating within a cross-functional team environment.
• Ability to manage multiple projects simultaneously.
• Strong research and analytical skills.
• Experience mentoring regulatory professionals or leading regulatory workstreams without direct supervisory authority.
• Strong interpersonal and influencing skills.
• Proficiency with Microsoft Word, Excel and PowerPoint.

Our Core Values:

• People – Our first responsibility is to the patients we serve.
• Integrity – Do the right thing
• Pioneering – Lead Boldly, Change Lives, Disrupt the Status-Quo
• Performance – Win together – Deliver with Excellence.

Saluda Medical embraces diversity and equal opportunity. We are committed to building a team representative of a variety of backgrounds, perspectives and skills. We believe people are the source of our inspiration and innovation.