Senior Regulatory Affairs Specialist

Job description

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. Reporting to the Sr. Director, Regulatory Affairs, the Senior Regulatory Affairs Specialist will provide input to global regulatory strategies and support submission activities for Saluda Medical’s product portfolio. What You'll Do: Prepare submissions for regulatory authorities Liaise with regulatory authorities for applications under review, and coordinate responses to queries Maintain product and site licenses, registrations, certificates, and listings Work closely with the Product Development team, providing regulatory guidance and input into the design of new products Assess proposed design, quality, and production changes to determine regulatory submission strategies Review technical documentation for accuracy and completeness to support regulatory submissions Monitor and review updates to regulations, standards, and guidance documents to ensure ongoing compliance to regulatory requirements Assist with development of labelling content and review for compliance prior to release Assist in the review of advertising and promotional materials in accordance with national regulatory requirements Provide mentorship for junior RA Specialists and interns What You'll Bring: Tertiary qualification in a science or engineering related discipline (e.g. software, biomedical, mechanical) Experience in medical device or other therapeutic goods industry, preferably in regulatory affairs Broad understanding of medical device regulations and relevant ISO standards associated with the product development and approval process Demonstrated experience in the management, compilation, submission, and maintenance of regulatory filings Proven experience working with cross functional teams in a commercial environment Strong written and verbal communication skills Effective time management and the ability to work autonomously Self-motivated team player, with a high level of personal integrity Demonstrated analytical skills and strong attention to detail to identify and resolve problems A strong desire to contribute to the growth of the company Desirable Requirements: Experience with European, US and/or Australian Medical Device Regulations Experience with Active Implantable and/or Class III medical devices Experience with Australian reimbursement requirements 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. Saluda Medical does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Saluda Medical’s approved agency list. Unsolicited resumes or candidate information submitted to Saluda Medical by search/recruiting agencies not already on Saluda Medical’s approved agency list shall become the property of Saluda Medical.