Post Market Surveillance Specialist I

ZOLL Medical Corporation • Chelmsford, MA

10d • $58,000 - $87,000 • Remote

About The Position

This role is part of ZOLL's Post Market Surveillance and Regulatory reporting program. Our Regulatory program is designed to meet the FDA's Quality System Regulation (QSR/Good Manufacturing Practices (GMP) and globally harmonized standard ISO 13485. Based on the information received, determine if events meet appropriate regulatory requirements for adverse event reporting. Generate appropriate regulatory reports based on assessment, communicate with our business partners globally, and respond to regulatory authority requests. This person will be instrumental in meeting Post Market Surveillance obligations surrounding submissions involving ZOLL devices domestically and internationally. There will be interdepartmental interactions surrounding Post Market Surveillance activity involving Quality Assurance Engineering, Compliance, Technical Support, Service, and Regulatory Affairs. This position performs evaluations, preparations for audits, review and submission of regulatory documents, and some oversight of the regulatory affairs program. There will be opportunities to showcase talents to improve, develop, and foster growth continuously.

Requirements

• Associate's or Bachelor's degree in related field required
• less than 1 year of related experience
• less than 1 year Quality and/or Regulatory experience in Medical Devices required
• less than 1 year Regulatory certification
• Knowledge of FDA 21 CFR Part 803 and ISO 13485, with experience in an FDA and ISO regulated Post Market Surveillance environment preferred.
• Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.
• Ability to work in collaborative and independent work situations and environments with minimal supervision.
• Excellent organizational skills with the ability to work within defined deadlines.
• Ability to work in collaborative and independent work situations and environments with minimal supervision.
• Ability to leverage and/or engage others to accomplish projects.
• Action-orientated: Ability to take initiative to correct problems or make changes for improvement without waiting for direction.
• Proven ability to work successfully with other departments.
• Proficiency in Microsoft Tools, including but not limited to Outlook, Teams, Excel, Access, Word
• A strong attention to detail leading to outstanding quality of work.
• Ability to manage time efficiently and effectively.
• Possesses a positive attitude.
• Analytical and forward thinker.
• Ability to take constructive feedback for continued improvement.

Nice To Haves

• exposure to Post Market Surveillance is preferred

Responsibilities

• Maintain ZOLL’s Post Market Surveillance documentation per ZOLL procedures and Regulatory requirements to stand on its own in the event of an audit.
• 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.
• 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 Post Market Surveillance databases, input data, and control access as needed.
• Maintain regular status reports of regulatory activities.
• Communicate and correspond with customers and team members effectively.
• Support departmental process improvements as they present.
• Collaborate with Quality Engineering for the timely completion of investigations and inquiries as required.

Benefits

• annual bonus in accordance with the company's bonus plan
• comprehensive benefits plans

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree