At Saluda, we challenge boundaries. We innovate and think beyond the conventional. We disrupt. With the passion and energy of an accomplished team of seasoned experts, our focus is to revolutionize the standard of care in the neuromodulation space by transforming the lives of patients suffering from debilitating pain.

Saluda is a global healthcare company that is redefining the Spinal Cord Stimulation (SCS) therapy at the intersection of advanced AI, real-time diagnostics, and ground-breaking clinical evidence. Every day at Saluda, we are focused on the dignity of responsibility to elevate human health and optimize clinician operations by unlocking the power of data and science to reach patients in need.

We are trailblazers and partners in the belief that smart, talented people, working as a team, can change the world. And we are in the process of building our US commercial team as we prepare to launch the first in a series of neuromodulation platforms in 2022. Our vision is to elevate the integrity and patient-centricity in the SCS category and we are looking for like-minded game-changers to help advance our mission.

What We're Looking For ...

This Senior Regulatory Affairs Manager, will have oversight for all Regulatory responsibilities. Ideally candidate will be able to commute to our Bloomington, MN corporate headquarters.

Job Duties:

• Manage submissions for regulatory authorities, including MDR applications and change notifications, TGA applications, FDA PMA and IDE applications and supplements and Q-subs;
• Supervise and mentor RA Specialists
• Liaise with regulatory authorities for applications under review, and coordinate responses to queries;
• Oversee product licenses, certificates, and listings for existing product portfolio;
• Work closely with the Product Development management team, providing regulatory guidance and input into the design of new and existing products;
• Assess proposed design, quality, and production changes to determine regulatory submission strategies;
• Review technical documentation for accuracy and completeness to support regulatory submissions;
• Manage labelling materials compliance projects;
• Manage reporting updates to regulations, standards, and guidance documents to ensure ongoing compliance to regulatory requirements;
• Manage the review of advertising and promotional materials in line with national regulatory requirements;
• Develop, implement and maintain new processes where required;
• Implement new regulatory processes as needed to comply to new regulations e.g., EU MDR;
  

Essential requirements:

• Degree in a relevant science (biomedical or neuro) or engineering related discipline;
• 8+ years experience regulatory affairs experience within the medical device industry (preferably with active implantable devices) including at least 2 years regulatory affairs management;
• Broad understanding of medical device regulations and relevant ISO/IEC 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 manager, 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.

Saluda Medical embraces diversity and equal opportunity in a serious manner. 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. The more inclusive we are, the better our work will be.