Qureos Mentor

MicroAire Surgical Instruments

<div>MicroAire Surgical Instruments LLC
As a part of the global industrial organization Marmon Holdings&mdash;which is backed by Berkshire Hathaway&mdash;you&rsquo;ll be doing things that matter, leading at every level, and winning a better way. We&rsquo;re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone&rsquo;s empowered to be their best.
MicroAire Surgical Instruments, (Charlottesville, VA) is a wholly-owned subsidiary and one of five companies within the Medical Group of Marmon Holdings, a Berkshire Hathaway company. MicroAire is a mid-sized medical device solutions company with a 45-year legacy of quality and innovation. With well-recognized brands, the company is uniquely positioned as a leader in specialty markets, including minimally invasive medical devices and equipment for aesthetics/reconstruction, and endoscopic soft tissue release. MicroAire designs, manufactures, and markets cutting-edge medical devices that empower surgeons to push the boundaries of surgical precision, delivering safe, efficient, and high-quality patient outcomes.
About the Role
Shape global access. Safeguard compliance. 
MicroAire is seeking a Regulatory Intelligence Specialist to lead international product registrations and sustain regulatory compliance across worldwide markets. You&rsquo;ll own regulatory pathways, partner with distributors and authorities, and collaborate across the business to ensure patients worldwide can access our medical devices safely and compliantly. This is a hybrid in office and remote role. Ideal candidates will be local or willing to relocate.
What You&rsquo;ll Do<ul><li>
Lead international registrations: Procure, prepare, review, and submit documentation for new and existing product registrations in OUS markets.</li><li>
Own regulatory partnerships: Engage with Ministries of Health, Regulatory Bodies/Agencies, and distributors to support registration, reporting, and compliance.</li><li>
Ensure distributor compliance: Maintain an approved distributor list and verify CE marking, declarations of conformity, complaint handling, storage/transport controls, and cooperation with authorities.</li><li>
Advise on license holder strategy: Determine the appropriate regulatory license holder/owner in each market to support compliance and business goals.</li><li>
Make strategic decisions: Recommend optimal pathways for new submissions and product changes by market; anticipate regulatory impacts and advise leadership.</li><li>
Coordinate with MedEnvoy &amp; partners: Liaise with MedEnvoy (Importer of Record for Switzerland and partners for EU/UK) and the Swiss Authorized Representative to ensure required reports and filings are completed, as applicable.</li><li>
Monitor global changes: Stay ahead of evolving worldwide requirements; flag risks and propose solutions.</li><li>
Report &amp; collaborate: Create progress reports for leadership, contribute to quarterly plans, and support Product Development and fellow Regulatory Affairs Specialists as needed.</li></ul>
What We&rsquo;re Looking For<ul><li>
Bachelor&rsquo;s degree in a related field or equivalent experience.</li><li>
5+ years of medical device OUS registration experience.</li><li>
Experience with distributors and foreign regulatory authorities.</li><li>
RAC certification preferred; experience with FDA 510(k), EU MDR/CE Mark, or Health Canada is a plus.</li><li>
Strong organization, documentation, and problem&#8209;solving skills; proficiency with Microsoft Office.</li></ul>
Regulatory Expertise 
Strong knowledge of OUS medical device regulations, QMS standards (FDA QSR, ISO 13485, MDSAP), and international registration pathways.
Strategic &amp; Analytical Thinking 
Evaluates regulatory pathways, anticipates changes, balances compliance with business needs, and manages competing priorities.
Collaboration &amp; Communication 
Works effectively with internal teams and international partners; strong technical writing and ability to simplify complex regulatory topics.
Project Management &amp; Detail Orientation 
Manages multiple submissions, maintains accurate documentation, and drives process improvements.
Business Acumen 
Understands how regulatory requirements impact market access, operations, and commercial strategy.<div></div>
Why MicroAire?
Join a mission-driven team where your regulatory expertise directly supports global patient access, strategic growth, and product safety.
Our Benefits:
<ul><li>Competitive compensation</li><li>
401K with company match</li><li>
Medical/Dental/Vision</li><li>
Vacation &amp; Paid Holidays</li><li>
Connection with Marmon Holdings companywide initiatives</li></ul>
Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.
We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.</div>

Regulatory Intelligence Specialist

Join MicroAire Surgical Instruments and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

MicroAire Surgical Instruments

ABOUT_COMPANY

Regulatory Intelligence Specialist