The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
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.
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
Perform other duties as assigned
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
Some travel is required ~10%
Required/ Preferred Education and Experience:
6+ years of regulatory experience in the Medical Device Industry
Experience with medical device regulatory submissions (510(k) or PMA)
Previous experience working with Regulatory Authorities relative to premarket and compliance activities.
Experience with medical device submissions.
Internal Number: R2792
About ZOLL Medical Corporation
ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.
We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!