Senior Regulatory Affairs Specialist

Saluda Medical

14d

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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