Senior Regulatory Affairs Program Lead

Resuscitation, ZOLLMED.com

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. 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 Regulatory Affairs Program Lead is responsible for managing the collaboration with cross-functional stakeholders to ensure regulatory compliance is met. The Senior Regulatory Affairs Program Lead will oversee the technical liaison(s) between cross-functional departments and the Regulatory Affairs team.

Essential Functions

• Ability to evaluate and resolve regulatory and technical issues due to extensive knowledge of medical device manufacturing and related regulatory requirements in this product sector through a clear understanding of the product development lifecycle.

• Lead technical medical device compliance initiatives, including assessing and communicating technical guidelines to support pre-market requirements.

• Drive education of regulatory compliance to key business stakeholders.

• Lead a team of product technical subject matter experts who support the Regulatory Regions teams to meet the requirements of regulatory bodies.

• Review global regulatory submissions for technical accuracy and regulatory compliance.

• Support technical inquiries for the medical device regulatory submissions, registrations, licenses, clearances, approvals, and deficiencies for global market entry.

• Initiate reviews of change requests and regulatory strategies for new product innovations or devices changes. Works collaboratively with the Regulatory Regions team to assess regulatory impact.

• Ability to lead a team to collaborate with Engineering and R&D to develop the standards strategy for medical devices and supports activities required to maintain regulatory compliance as new or revised versions of standards are released.

• Ability to lead a team to collaborate with R&D and Quality Assurance in the development of risk management plans and hazard analysis for ZOLL products.

• Ability to lead a team to collaborate with key stakeholders to ensure and improve efficiencies throughout design documentation in accordance with regulatory requirements and best practices.

• Identify, plan and implement key projects to improve internal processes resulting in significant efficiency improvements.

• Communicates clearly and effectively with cross-department personnel.

• Participate in regulatory audits/inspections as required.

• Author and maintain standard operating procedures (SOPs) and train key personnel as needed.

Required/Preferred Education and Experience

• Bachelor's Degree required

• 7+ years of regulatory experience in the Medical Device Industry

• Previous experience working with Regulatory Authorities relative to premarket and compliance activities.

Knowledge, Skills and Abilities

• Exemplary project management skills. Expert ability to prioritize, conduct, and manage time to meet project deadlines

• 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

• Experience interacting with FDA and/or other regulatory agencies

• Exhibits strategic thinking skills

• 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

• Documented evidence of writing skills

• Basic understanding of computer applications

• Strong understanding of medical terminology

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.

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.