Principal Regulatory Affairs Program Specialist

ZOLL Medical Corporation•Chelmsford, MA

23h•$130,000 - $144,000

About The Position

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 Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. 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 The Principal Regulatory Affairs Program Specialist supports new and sustaining project teams for ZOLL Resuscitation products and features. The Principal Regulatory Affairs Program Specialist is the technical liaison between cross-functional project teams and Regulatory Affairs, including the OEM and Regional Regulatory Affairs team members. The Principal Regulatory Affairs Program Specialist represents the Regulatory Affairs team through the review and approval, where applicable, of project level product documentation and review/approval of Change Requests and Change Orders. The Principal Regulatory Affairs Program Specialist develops a global strategy, in collaboration with the Regional Regulatory Affairs team, to support their assigned projects.

Requirements

Bachelor's Degree in Relevant Technical Discipline, required, such as Science or Engineering required
8+ years of regulatory affairs experience in the medical device, pharmaceutical, biologics industry, required
3+ years of experience in electro-mechanical and/or software medical products, required.
Submission writing experience, required
Project management skills
Experience developing and executing regulatory strategies to support successful regulatory affairs team.
Effective, evidence-based writing skills for internal and external audiences
Effective verbal communication skills to interface with diverse internal and external stakeholders.
Experience interacting with FDA and/or other regulatory agencies
Ability to create action plans, manage and monitor progress, and drive completion of RA project deliverables.
Supports team members in the preparation of suitable written responses to Regulatory Inquiries.
Must be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolution
Must demonstrate leadership skills in team setting

Nice To Haves

Advanced Degree in a Relevant Technical Discipline or Master’s Degree in Regulatory Affairs, Preferred
Regulatory Affairs Certification Preferred
Experience in the electro cardiology or defibrillation/respiratory space preferred.

Responsibilities

Technical Product Subject Matter Expert for Regulatory Affairs – Act as the designated RA technical expert for multiple ACT division product lines, applying product, engineering, clinical, and risk management knowledge to shape regulatory pathways and submission strategy. Synthesize complex cross-functional inputs into clear, strategically aligned regulatory deliverables and messaging tailored to global regulatory authorities and stakeholders at all organizational levels. Effectively communicates complex regulatory information to clear and understandable concepts for stakeholders with varying levels of regulatory knowledge
Support Cross-Functional NPI and Sustaining Project Teams and providing clear and actionable regulatory guidance. Reviews and approves change requests and change orders for new product innovations and devices changes. Works collaboratively with the Regional Regulatory Affairs team to assess regulatory impact and plan implementation.
Develop and successfully manage regulatory strategies for new and sustaining products/features that result in device approval.
Provide clear strategic regulatory guidance during the development, review, and approval of internal and external documentation to support the development and commercialization of assigned product(s)
Work with regional RA and product teams to ensure that regulatory requirements are appropriately considered and accounted for in programs and projects.
Collaborate with cross-functional and regional RA teams to develop regulatory deliverables for global submissions.
Provide technical documentation for medical device regulatory submissions including 510(k), PMAs, Technical Files or Design Dossiers, and other pertinent regional registrations, licenses, clearances, approvals, and deficiencies for global market entry.
Review global regulatory submissions for technical accuracy and regulatory compliance.
Collaborate with Engineering and R&D to develop the standards strategy for medical devices and supports activities required to maintain regulatory compliance as new or revised versions of standards are released.
Collaborate with R&D and Quality Assurance in the review of risk management plans and hazard analysis for ZOLL products.
Author and maintain standard operating procedures (SOPs) and train key personnel, as needed
Maintain current knowledge of global regulations and guidance and drive education of regulatory compliance to key business stakeholders
Prepare and collaborate with cross-functional resources for internal and external audits. Collaborate with regional RA, if applicable, on responses to audit questions.
Support a culture of continuous improvement by promoting best practices, fostering innovation, and recognizing and celebrating achievements as well as monitor and report on key performance indicators (KPIs) to track the progress and impact of continuous improvement efforts.