Regulatory Affairs Specialist (Principal) Position Summary We are seeking an experienced Regulatory Affairs Specialist to support and guide the regulatory strategy for a portfolio of medical devices. This role will serve as a key advisor to executive leadership and provide regulatory insight across the product lifecycle, with particular emphasis on higher‑risk devices and global market considerations. Key Responsibilities Provide strategic regulatory leadership for Class II and Class III medical devices from development through commercialization and lifecycle management. Interpret and apply global regulatory requirements to inform business and product strategy. Advise senior leadership and the Board of Directors on regulatory risks, opportunities, and compliance considerations. Contribute to the development and execution of regulatory strategies aligned with corporate objectives. Serve as a subject matter expert on regulatory frameworks, standards, and evolving regulatory expectations. Support cross‑functional teams by providing regulatory guidance related to design, clinical, quality, manufacturing, and post‑market activities. Represent regulatory interests in internal discussions and, as needed, external interactions with regulatory bodies or partners. Monitor regulatory trends and assess potential impacts to the organization's pipeline and long‑term strategy. Qualifications 10+ years of experience in medical device regulatory affairs. Demonstrated experience supporting or leading regulatory strategy for Class II and Class III medical devices. Broad understanding of global medical device regulatory requirements and compliance expectations. Proven ability to communicate complex regulatory concepts to non‑regulatory stakeholders, including executives and board members. Strong strategic thinking, professional judgment, and stakeholder engagement skills. #J-18808-Ljbffr EPM Scientific
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