Senior Regulatory Affairs Specialist, APAC

Job description

Acute Care Technology 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 Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service. At ZOLL, you won’t just have a job. You'll have a career—and a purpose. Join our team. It’s a great time to be a part of ZOLL! Job Summary The Senior Specialist, Regulatory Affairs is responsible for preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities. Essential Functions Supports in developing partnerships with quality assurance, manufacturing, program management, product development, and marketing to ensure product compliance and timely product clearances and/or approvals. Represent regulatory affairs on project/product teams, risk management, and all design review meetings. Working with department management provides regulatory guidance and guidance on applicable standards to cross-functional groups Working with department management provides global regulatory strategies and regulatory plans Working with department management, communicates with US FDA, EU Notified Bodies, EU Competent Authorities and other international regulatory authorities Coordinates/prepare and maintains FDA PMA and 510(k) Premarket Notifications in accordance with US FDA requirements Coordinates/prepare and maintains CE files in accordance with current Medical Device Directive requirements, manages Essential Requirement checklists and ensures timely updates for all applicable CE certifications Coordinates and prepares responses to FDA/NB or other such regulatory agency letters. Supports Reviews of product labeling changes Reviews promotional literature and marketing materials Support CAPA and CAPA closure Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company Participates in regulatory audits/inspections as required Writes SOPs and train key personnel as needed Required/Preferred Education and Experience Bachelor's Degree required 6+ years of regulatory experience in the Medical Device Industry required and Experience with medical device regulatory submissions (510(k) or PMA) required and Previous experience working with Regulatory Authorities relative to premarket and compliance activities. required and Experience with medical device submissions required Knowledge, Skills and Abilities Project management skills Degree in RA or Regulatory Affairs Certification a plus Must be able to work under pressure to meet regulatory reporting time frames and company requirements Must be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolution Knowledge of U.S. and European/International regulations and standards Experience interacting with FDA and/or other regulatory agencies Must work well in team environments Must demonstrate leadership skills in team setting. Proven analytical abilities, Able to apply problem-solving skills for problems of moderate to diverse scope Solid understanding of manufacturing and change control, and an awareness of regulatory trends Understanding of engineering concepts and scientific terminology Superior interpersonal skills Excellent communication skills, both oral and written Proven ability to prioritize, conduct, and manage time to meet project deadlines Documented evidence of writing skills Basic understanding of computer applications Familiarity with medical terminology a plus Travel Requirements 10% travel required 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.