Senior Specialist, Regulatory Affairs
📋 Role Overview & Responsibilities
Location: Chelmsford, MA
Resuscitation
At ZOLL, we're passionate about improving patient outcomes and helping save lives.
We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Acute Care Technology division of ZOLL develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.
At ZOLL, you won’t just have a job. You’ll have a career—and a purpose.
Join our team. It’s a great time to be a part of ZOLL!
Job Summary
Develop, implement, and lead the regulatory regional strategy, in alignment with company goals, for new and sustaining ZOLL Resuscitation products and features.
Essential Functions
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).Work 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.Work with management on risk assessment and regulatory compliance.Support Cross-Functional NPI Project Teams and provide regulatory guidance.Maintain current knowledge of regulations and guidance and collaborate with product teams on approvals and disseminate information and generate potential strategies with teams.Lead, support, and coordinate with internal and external resources to meet audit and compliance requirements.Support a culture of continuous improvement by promoting best practices, fostering innovation, and recognizing and celebrating achievements as well report on key performance indicators (KPIs) to track the progress and impact of continuous improvement efforts.
Required/Preferred Education And Experience
Bachelor's Degree requiredAdvanced Degree preferred5+ years of regulatory affairs experience preferably in the medical device industry, with proven experience in electro-mechanical products requiredRegulatory Affairs Certification Preferred
Knowledge, Skills And Abilities
Experience building regulatory strategies to support successful regulatory affairs team.Proven written and verbal communication skills to interface with a variety of stakeholders.Ability to create action plans and project deliverables.Supports team members in the preparation of suitable written responses to Regulatory Inquiries.Experience in the electro cardiology or defibrillation/respiratory space preferred.
Travel Requirements
Requires travel (:5% - 10%)
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Standing - OccasionallyWalking - OccasionallySitting - ConstantlyTalking - OccasionallyHearing - OccasionallyRepetitive Motions - Frequently
ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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This position is located in Chelmsford, MA with potential relocation and sponsorship assistance depending on candidate qualifications.
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