Senior Regulatory Affairs Specialist

About this role

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.
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

Qualifications:

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.
Originally posted on Himalayas