Senior Specialist, Regulatory Affairs

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.
• 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.

Required/Preferred Education And Experience

• Bachelor's Degree required
• Advanced Degree preferred
• 5+ years of regulatory affairs experience preferably in the medical device industry, with proven experience in electro-mechanical products required

Regulatory 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

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

Pay

The Annual Salary For This Position Is $101,600.00 to $152,400.00

Benefits

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.