ZOLL Medical
Senior Specialist, Regulatory Affairs
US MA Remote · Senior
Sponsorship not specified$102k-$152kDetected 16 days ago
FDA RegulatoryMedical DevicesCommunicationRegulatory Affairs
About the role
- 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.
Responsibilities
- Develop, implement, and lead the regulatory regional strategy, in alignment with company goals, for new and sustaining ZOLL Resuscitation products and features.
- Develop and successfully implement regional regulatory strategies for new and sustaining products/features that result in device approval.
- 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).
- 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.
- Lead, support, and coordinate with internal and external resources to meet audit and compliance requirements.
- Experience building regulatory strategies to support successful regulatory affairs team.
Requirements
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Nice to have
- 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.
- Work with RA regional and product teams to ensure that regulatory requirements are appropriately considered and accounted for in programs and projects.
- Work with management on risk assessment and regulatory compliance.
- Bachelor's Degree required
- Advanced Degree preferred
- Regulatory Affairs Certification Preferred
Skills
- Knowledge, Skills and Abilities
- Proven written and verbal communication skills to interface with a variety of stakeholders.
Compensation
- $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
- This position is eligible for an annual bonus in accordance with the company's bonus plan.
- Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.
Company info
- ZOLL is a fast-growing company that operates in more than 140 countries around the world.
- Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit.
Equal opportunity
- 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.
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This listing is sourced directly from ZOLL Medical's careers page and normalized into a canonical job model.