Senior Regulatory Affairs Specialist

EPM Scientific is partnered with an established medical device innovator developing life-changing technologies that address critical patient needs in the cardiovascular and interventional space. As the company continues to expand its global footprint, they are seeking a Senior Regulatory Affairs Specialist to support regulatory strategy, submissions, and global compliance activities across the product lifecycle. This is an excellent opportunity for a hands‑on regulatory professional who enjoys working cross-functionally with R&D, Clinical, Quality, and Commercial teams while contributing directly to global product development and regulatory success. Key Qualifications Bachelor's degree in a scientific discipline or related field required. 3-5+ years of Regulatory Affairs experience within the medical device industry. Strong knowledge of global medical device regulations and product development processes. Experience preparing and supporting regulatory submissions for international markets. Understanding of quality systems and their relationship to regulatory compliance. Ability to interpret regulatory requirements and provide guidance to cross-functional teams. Strong technical writing, organizational, and project management skills. Excellent communication and stakeholder management abilities. Experience with Class III medical devices preferred. Cardiovascular device experience is highly desirable. Prepare, submit, and maintain global regulatory filings, registrations, annual reports, and submission amendments. Support interactions and correspondence with global regulatory authorities and notified bodies. Partner with product development and sustaining engineering teams to ensure regulatory requirements are incorporated throughout the development process. Interpret regulatory requirements related to product design, clinical studies, testing, labeling, and post‑market activities. Support adverse event reporting, Medical Device Reports (MDRs), vigilance reporting, and other regulatory communications. Review and provide regulatory input on risk management documentation, technical reports, and related product documentation. Ensure product labeling remains compliant with applicable global regulations. Monitor evolving regulatory requirements and communicate potential impacts to the business. Review document change orders and support regulatory assessments for product changes. Participate in internal and external audits as needed. Maintain regulatory intelligence and contribute to continuous improvement of regulatory processes and procedures. Benefits Comprehensive medical, dental, and vision coverage 401(k) with company match Competitive PTO and paid holidays Career development and advancement opportunities Collaborative and mission‑driven culture Opportunity to work on innovative medical technologies with global impact #J-18808-Ljbffr