Senior Specialist, Regulatory Affairs
About the role
Develop, implement, and lead the regional regulatory strategy, in alignment with company goals, for new and sustaining ZOLL Resuscitation products and features.
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 as reporting on key performance indicators (KPIs) to track the progress and impact of continuous improvement efforts.
- Requires travel (~5% - 10%).
Requirements
- 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
Qualifications
- 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.
Pay
The Annual Salary For This Position Is $101,600.00 to $152,400.00. 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. 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.
Benefits
Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.
Schedule
Open to Hybrid / Remote