Hiring: Senior Specialist, Regulatory Affairs Company: ZOLL Medical Corporation Location: Middlesex County, MA Job Posted Time: 2026-09-16 14:43:47 Employment Type: Remote Target Skills & Keywords : Regulatory Compliance About the job Experience: •5+ years of regulatory affairs experience preferably in the medical device industry, with proven experience in electro-mechanical products required Required Skills: •Develop, implement, and lead the regulatory regional strategy, in alignment with company goals, for new and sustaining ZOLL Resuscitation products and features. •Develop and successfully implement regional regulatory strategies for new and sustaining products/features that result in device approval. •Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. •Provide strategic regional regulatory perspective during the development, review, and approval of internal and external documentation to support the development and commercialization of assigned product(s). •Interface directly with RA regional and product teams to ensure that regulatory requirements are appropriately considered and accounted for in programs and projects. •Author and prepare submittals of IDEs, 510(k), PMAs, Technical Files or Design Dossiers, and other pertinent regional device applications. •Interface directly with management on risk assessment and regulatory compliance. •Support Cross-Functional NPI Project Teams and provide regulatory guidance. Qualifications: •Proven written and verbal communication skills to interface with a variety of stakeholders. •Demonstrated capacity to create action plans and project deliverables. •Supports team members in the preparation of suitable written responses to Regulatory Inquiries. •Bachelor's Degree required Compensation: •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!