The Regulatory Affairs Director will have oversight for all Regulatory responsibilities. 

Job Duties:

• Manage submissions for regulatory authorities, including FDA PMA, IDE, and Qsub applications, European MDR application and country registrations, TGA applications, 
• 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 g., EU MDR;

Essential requirements:

• Degree in a relevant science (biomedical or neuro) or engineering related discipline;
• 10 years experience regulatory affairs experience within the medical device industry (preferably with active implantable devices) including at least 4 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.

At Saluda, people are the source of our inspiration and innovation. We are excited by new ideas and believe many of the greatest discoveries come from a diversity of minds, backgrounds and experiences. As an inclusive workplace, we encourage employees to bring their authentic, whole selves to work. The more inclusive we are, the better our work will be.”

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.