Principal Regulatory Affairs Program Specialist

• 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.

• 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
• Advanced Degree in a Relevant Technical Discipline or Master's Degree in Regulatory Affairs, Preferred
• Regulatory Affairs Certification Preferred

• 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.
• Experience in the electro cardiology or defibrillation/respiratory space preferred.
• Must be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolution
• Must demonstrate leadership skills in team setting

• Requires travel (~5% - 10%).
  

• Standing - Occasionally
• Walking - Occasionally
• Sitting - Constantly
• Talking - Occasionally
• Hearing - Occasionally
• Repetitive Motions - Frequently

The annual salary for this position is:

This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.

Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.

ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.