Post Market Surveillance Senior Specialist

1 day ago

Chelmsford, United States Zoll Medical Corporation Full time
Resuscitation 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 ACT division of ZOLL develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service. At ZOLL, you wont just have a job. You'll have a careerand a purpose. Join our team. Its a great time to be a part of ZOLL Job Summary This stakeholder opportunity resides in ZOLL's Post Market Surveillance program designed to meet FDA's Quality System Regulation (QSR)/ Good Manufacturing Practices (GMP), MDD, EU MDR, MDSAP, and the globally harmonized standard ISO 13485. This person will work with surrounding departments such as Quality Assurance, Compliance, Technical Support, Service, and Regulatory Affairs. Involved in several aspects of Post Market Surveillance leveraging talents to demonstrate compliance with Regulatory requirements worldwide. We pride ourselves on creating opportunities for growth. Essential Functions Maintaining ZOLL's Post Market Surveillance in compliance within applicable regulations worldwide. Support process improvement and continuous improvement initiatives Stay appraised with regulatory landscape updates, changes, and state of the art. Support initiatives to implement and assess gaps in the Quality Management System as it relates to Post Market Surveillance. Ensure reporting requirements are compliant with ZOLL Policy in accordance with applicable laws and regulations worldwide. Establish and maintain department metrics that compliment ZOLL goals, targets, and objectives. Establish and encourage dynamic communication within all facets of ZOLL related to an effective Post Market Surveillance program. Provide support for annual reporting, CERs, and PMA activities related to Post Market Surveillance. Stay appraised of latest developments in the regulatory landscape related to Post Market Surveillance Maintain Quality Management System procedures related to applicable Post Market Surveillance responsibilities and promote continuous improvement. Able to communicate tactfully with the FDA and other regulatory agencies. Maintain regular status reports of regulatory activities. Prepare reports and metrics for Post Market Surveillance to be used in monthly staff meeting and Management Review Quarterly meetings. Communicate and support other ZOLL facilities and business partners globally as required. Support Competent Authority inquiries, Adverse Event & Serious Injury reporting, and Risk Management activities world-wide. Maintain positive and cooperative communications in collaboration with all levels of employees and customers. Participate in the mentoring of department personnel for acclimation and growth. Work closely with Regulatory, Clinical Affairs, Quality Assurance personnel to align with Post Market Surveillance activities Support auditing activities related to Post Market Surveillance Required/Preferred Education and Experience Bachelor's Degree preferred 3-5 yrs. related experience preferred Certification in Regulatory Affairs program Preferred Knowledge, Skills and Abilities Has knowledge of commonly used concepts, practices, and quality tools, in a medical device environment (preferred). Proficient with MS Office, including Excel, Access, PowerPoint, Visio and Word. Oracle and Agile experience preferred. Knowledge of FDA QSR, 803, MDD, MDR, ISO13485, and MDSAP is preferred. 2-5 years experience in an FDA and ISO regulated environment preferred. Knowledge of Post Market Surveillance, including but not limited to complaint handling and remedial action. Ability to provide leadership, communicate and work effectively within a multi disciplined organization. Strong verbal and written communications with 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 handle multiple priorities to meet deadlines. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. 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. Physical Demands 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. Standing - Occasionally Walking - Occasionally Sitting - Constantly Talking - Occasionally Hearing - Occasionally Repetitive Motions - Frequently 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. ZOLL appreciates and values diversity. We are an Equal Opportunity Employer M/F/D/V. ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990 LI-LV1 LI-HYBRID All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. J-18808-Ljbffr

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