Regulatory Affairs Specialist

Job Description

About Consure Medical:

Consure Medical is a fast-growing, innovation-driven medical device company that is fundamentally changing critical care. We have built a portfolio of first-of-its-kind products in incontinence management, skin health, infection prevention, and critical care — technologies that deliver superior clinical outcomes, dramatically reduce healthcare costs, and expand access for patients worldwide.

Our solutions are sold globally, protected by robust intellectual property, backed by rigorous regulatory clearances, comprehensive clinical evidence, and manufactured to the highest quality standards. We operate at the ideal scale: agile enough for rapid progress, yet equipped with the resources and ambition to launch pioneering products on the global stage.

The Opportunity:

This is a rare, high-visibility opportunity for a Regulatory Affairs Specialist ready to step out of large MNC teams or client-focused consulting projects and take true ownership of global regulatory strategy for breakthrough medical technologies.

If you're currently in a large organization where your impact feels diluted across layers of hierarchy, or in consulting where you deliver projects but rarely see the full journey from submission to commercial launch and real clinical impact — this role is your chance to move to the global stage with end-to-end accountability.

You will directly advance our already-cleared Class I and II portfolio while leading complex, high-stakes submissions (FDA 510(k), De Novo, IDE/PMA pathways, EU MDR CE Marking, and challenging new-market clearances in Japan, Canada, KSA, Brazil, and beyond). You will own critical documentation, shape regulatory strategy, and represent the company with confidence before global authorities. In a flat, high-ownership culture, you'll work hands-on with visionary R&D, clinical, and quality teams — turning regulatory excellence into faster patient access to life-changing innovations.

Key Responsibilities:

• Develop and execute comprehensive global regulatory strategies to support product development, clinical programs, and commercialization across the U.S., EU, UK, India, Israel, MENA, Latin America, Asia-Pacific, and additional high-growth markets.
• Prepare, review, and manage complex regulatory submissions, including 510(k), De Novo, IDE, PMA, EU MDR Technical Documentation, UKCA, and other international registrations.
• Own and maintain essential regulatory files, including Design History Files (DHF), Technical Files / Technical Documentation, Risk Management Files (RMF), and all related quality records.
• Lead interactions with regulatory authorities, notified bodies, and authorized representatives — including high-stakes presentations, responses, and negotiations to secure and maintain approvals.
• Ensure Class I and II devices (with exposure to Class III pathways) meet all applicable regulatory requirements, standards, and guidelines.
• Partner closely with R&D, Quality, Clinical, and Manufacturing teams to integrate regulatory requirements seamlessly throughout the product lifecycle.
• Support risk management (ISO 14971), biocompatibility (ISO 10993), post-market surveillance, vigilance reporting, and ongoing compliance activities.
• Provide strong regulatory leadership during internal audits, external inspections, and agency reviews — demonstrating maturity, presence, and the ability to successfully defend submissions.
• Monitor evolving global regulatory intelligence and proactively assess impact on products, strategy, and business operations.

Requirements (We Hire for Expertise, Ownership & Mindset):

• ·Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, Electronics, Life Sciences, or a related discipline.
• 3–5 years of hands-on Regulatory Affairs experience in medical devices, with a proven track record of successful FDA and CE MDR submissions for Class I and II devices (Class III or PMA/IDE experience is a strong plus).
• Direct experience preparing and maintaining Design History Files (DHF), Technical Files, and supporting global regulatory clearances.
• In-depth knowledge of key standards and regulations: FDA 21 CFR 820, EU MDR 2017/745, UKCA, ISO 13485, ISO 14971, IEC 60601, IEC 62304, and ISO 10993.
• Exceptional written, verbal, and presentation skills with the professional maturity and gravitas to lead company-wide interactions with regulatory bodies and confidently defend positions during audits.
• A proactive, hands-on, tactical mindset with a genuine hunger for the latest regulations, tools, and best practices — you thrive in a fast-paced, non-hierarchical environment where you own outcomes and get things done.