Sr Manager Regulatory Affairs & Quality Assurance

Lumira Search is partnered with an innovative neurovascular medical device start-up as we look to recruit a Regulatory Affairs Manager / Senior Manager (with Quality oversight) in South Florida. Exceptional candidates at VP and Director level will also be considered.Our client is an early-stage neurovascular company developing a novel Class II device platform. They are moving towards FDA submission, clinical evidence generation and commercialisation. This role will lead the regulatory pathway to market and build the quality foundations to support it.Location – South Florida (Onsite)The RoleThis is a hands-on, regulatory-led position covering both strategy and execution. You will own the U.S. regulatory strategy and the FDA submission process, while overseeing quality systems as the company grows. You will work closely with R&D, clinical and senior leadership.

Responsibilities

Own U.S. regulatory strategy for Class II active medical devices, including 510(k), Q-sub/pre-sub and FDA correspondenceLead the authoring, compilation and submission of 510(k) and pre-sub packagesAct as the primary point of contact with the FDA, including managing additional information requests and feedbackDefine predicate strategy and partner with R&D on testing strategy, biocompatibility, electrical safety, software documentation and labelling/IFUsTranslate FDA feedback into clear execution plans for cross-functional teamsOversee the QMS, design controls, DHF, risk management and V&V documentation to ensure they are submission-readyManage external regulatory and quality consultants, testing vendors and documentation contributorsPrepare the organisation for audits, inspections and supplier quality reviewsAdvise senior leadership on regulatory risk, timelines and key decision pointsIdeal Background:6+ years in medical device regulatory affairs, with quality assurance experience highly advantageousDirect experience with Class II devices, ideally active or electromechanical systemsStrong knowledge of design controls, DHF, risk management (ISO 14971), ISO 13485 and 21 CFR 820Neurovascular, cardiovascular, peripheral vascular, thrombectomy, catheter, pump, aspiration or surgical device experience strongly preferredEarly-stage or growth-stage medical device experience is advantageousStrong technical writing and the ability to turn ambiguity into an executable regulatory planRAC certification is a plus. CQE, CQA or ISO 13485 Lead Auditor experience is also beneficial.Must Have:Direct, hands-on involvement in preparing and submitting at least one 510(k) to the FDABased in South Florida or willing to relocate independentlyAble to work fully onsiteComfortable in a fast-moving start-up environmentWhat's on Offer:This is a high-impact role within a rapidly evolving organisation, with the chance to lead the regulatory strategy for a differentiated neurovascular technology with strong physician and investor support. The package includes a competitive base salary and equity.To be considered, please send your resume alongside a brief note outlining your 510(k) submission experience and why you are a strong fit for the role to: wskelton@lumirasearch.comPlease note: Due to the high volume of applications, only candidates who meet the criteria will be contacted. If you have not heard back from me within 14 days of applying, please assume your application has been unsuccessful.