Senior Regulatory Affairs Specialist

Core Responsibilities Manage and resolve regulatory information requests by delivering accurate, complete, and audit‑ready data packages aligned with global regulatory expectations. Conduct structured regulatory risk assessments, perform impact analyses on design and manufacturing changes, and communicate mitigation strategies to cross‑functional engineering, quality, and clinical teams. Support end‑to‑end regulatory submissions through detailed reviews of product labeling, clinical and human‑factors study protocols, verification/validation documentation, and quality system records. Lead development of global regulatory pathways by coordinating with international regulatory counterparts to execute product registrations, renewals, and maintenance activities across multiple regions. Ensure alignment with internal quality system requirements by authoring and updating controlled procedures, work instructions, and regulatory‑impact documentation. Uphold organizational standards for compliance, data integrity, engineering collaboration, and technical accountability. Contribute technical expertise to additional regulatory or quality initiatives as assigned. Minimum Qualifications Bachelor’s degree in a scientific, engineering, or regulated‑industry discipline. 5+ years of experience in regulatory affairs or quality engineering within the medical device sector, including Working knowledge of U.S. regulatory and quality frameworks (e.g., medical device regulations, quality system requirements, and applicable FDA/industry standards spanning clinical practice, laboratory practice, and design controls). Ability to support limited domestic or international travel (approx. 15%). Preferred Technical Skill Set Demonstrated capability to deliver regulatory leadership throughout the product lifecycle, including regulatory strategy development, design change assessment, submission planning and documentation review. Strong technical writing proficiency with experience authoring structured regulatory submissions for diverse global markets. Expertise using productivity and project‑management software to manage timelines, technical documentation and cross‑functional deliverables. Proven communication and collaboration skills, enabling effective interface with engineering, quality, clinical, and manufacturing functions. Strong organizational capability with the discipline to manage multiple technical workstreams concurrently. Experience supporting global regulatory operations and coordinating with geographically distributed teams. Regulatory Affairs Certification (RAC) is preferred. #J-18808-Ljbffr