Senior Regulatory Affairs Specialist

Job not on LinkedIn

🔥 12 hours ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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

• 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

🎯 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 • Experience with European, US and/or Australian Medical Device Regulations (desirable) • Experience with Active Implantable and/or Class III medical devices (desirable) • Experience with Australian reimbursement requirements (desirable)

🏖️ Benefits

• Saluda Medical embraces diversity and equal opportunity • Committed to building a team representative of various backgrounds, perspectives, and skills • Belief that people are the source of inspiration and innovation