Senior Quality and Regulatory Specialist

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 Respicardia division of ZOLL Medical Corporation is focused on helping people with central sleep apnea get access to a therapy to restore a more normal breathing pattern during sleep and give them better quality of life. We develop breakthrough therapies for an impactful disease that is severely underdiagnosed and often untreated.

As we continue to grow, those who join our team will work alongside motivated people who care about others, put patients first and are dedicated to high-quality and innovative solutions.

Job Type

Remote

Job Summary

Oversee regulatory compliance activities, provide quality/regulatory expertise, and drive continuous improvement in the quality management system to meet policies, regulations, and business needs.

Essential Functions

• Develop, improve, and maintain regulatory process SOPs, work instructions, and QMS procedures.
• Support global regulatory submissions, change notifications, annual reports, and change impact assessments.
• Review and assist in labeling plans, support, and label review.
• Maintain technical and submission documentation, aiding in its creation when necessary.
• Drive Regulatory Knowledge Management, monitor changing regulations/standards, conduct gap assessments, implement changes.
• Conduct internal and supplier audits, support external audits, manage CAPA process, and support clinical quality and other quality assurance activities as assigned.
• Support Quality System and Clinical Trial documentation and activities.
• Lead improvement projects by collaborating across functions.
• Manage regulatory supplier relationships and share updated documentation.
• Generate KPI metrics, analyze data, and report on QMS and product feedback.
• Train and mentor cross-functional teams.
• Stay informed about medical device regulatory trends, provide insights.
• Assist in site quality assurance tasks as required.
• Aid in issue/complaint and regulatory reporting.
• Fulfill other assigned tasks from management as required.

Required/Preferred Education and Experience

• Bachelor's Degree in Biomedical Engineering or Life Sciences required
• Master's Degree in Biomedical Engineering or Life Sciences preferred
• 5-10 years of industry experience required
• Auditor certification Preferred
• RAC certification Preferred

Knowledge, Skills and Abilities

• Expertise in ISO 13485, ISO 14971, EU MDR 2017/745, and 21 CFR 820.
• Knowledgeable with ISO 14155, FDA GCP Regulations (21 CFR 812, 56, 50).
• Excellent problem-solving and decision-making skills.
• Thorough understanding of U.S. and international regulations.
• Statistical and data analysis proficiency for QMS and product feedback.
• Effective project management and time management.
• Excellent communication and coaching abilities.
• Regulatory compliance audit experience (ISO 13485, 21 CFR 820, GCP).
• Exposure to PMA, change notifications, 510(k)s submissions.
• Experience with medical devices is required and experience with Class III implantable medical devices is a plus

Travel Requirements

• 10% travel (may include locally, domestically, and/or internationally)

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. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.