ZOLL Cardiac Management Solutions · 16 hours ago
Senior Specialist, Regulatory Affairs
Chelmsford, MA
Full-time
Hybrid
Mid, Senior Level
$90K/yr - $130K/yr
5+ years expZOLL Cardiac Management Solutions is dedicated to improving patient outcomes through innovative medical technologies. The Senior Specialist in Regulatory Affairs will develop and lead regulatory strategies for ZOLL Resuscitation products, ensuring compliance and successful approvals.
Medical Device
Responsibilities
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
Qualification
Required
Bachelor's Degree required
5+ years of regulatory affairs experience preferably in the medical device industry, with proven experience in electro-mechanical products required
Preferred
Advanced Degree preferred
Regulatory Affairs Certification Preferred
Experience in the electro cardiology or defibrillation/respiratory space preferred
Benefits
Annual bonus in accordance with the company's bonus plan
Comprehensive benefits plans
Company
ZOLL Cardiac Management Solutions
ZOLL Cardiac Management Solutions (CMS), a division of ZOLL Medical Corporation, offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes in cardiac patient care.
1001-5000 employees
H1B Sponsorship
ZOLL Cardiac Management Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (1)
2021 (1)
2020 (2)
Funding
Current Stage
Late StageCompany data provided by crunchbase