ZOLL Medical

Post Market Surveillance Specialist I

Chelmsford, MA

Sponsorship not specified$58k-$87kDetected 15 days ago

ExcelAuditingCustomer SupportGMPFDA RegulatoryMedical DevicesCommunicationOrganizational SkillsMicrosoft OfficeRegulatory Affairs

About the role

This role is part of ZOLL's Post Market Surveillance and Regulatory reporting program.
This person will be instrumental in meeting Post Market Surveillance obligations surrounding submissions involving ZOLL devices domestically and internationally.
Communicate and correspond with customers and team members effectively.

There will be interdepartmental interactions surrounding Post Market Surveillance activity involving Quality Assurance Engineering, Compliance, Technical Support, Service, and Regulatory Affairs.
There will be opportunities to showcase talents to improve, develop, and foster growth continuously.
Maintain ZOLL's Post Market Surveillance documentation per ZOLL procedures and Regulatory requirements to stand on its own in the event of an audit.
Support Competent Authority inquiries, Adverse events, and Serious Injury reporting, and Risk Management activities worldwide.
Coordinate and maintain closure of complaint records in our Post Market Surveillance system.
Provide support for Post Market Surveillance activities and training of PMSR coordinators and specialists as needed.
Support the review and evaluation of customer communications for complaint reporting obligations.
Support auditing activities related to Post Market Surveillance
Maintain regular status reports of regulatory activities.
Support departmental process improvements as they present.

Proven ability to work successfully with other departments.
Proficiency in Microsoft Tools, including but not limited to Outlook, Teams, Excel, Access, Word
Ability to take constructive feedback for continued improvement.

Comply with U.S. Food and Drug Administration (FDA) regulations and other international regulatory requirements, company policies, operating procedures, processes, and task assignments.
Completion and submission of documentation for reportable events to Competent Authorities within required timelines.
Collaborate with Quality Engineering for the timely completion of investigations and inquiries as required.
Associate's or Bachelor's degree in related field required

$58,000.00 to $87,000.00
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.

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.

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's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit.

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.

This listing is sourced directly from ZOLL Medical's careers page and normalized into a canonical job model.