Regulatory Affairs Program Lead
1 month ago
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 Regulatory Affairs Program Lead is responsible for managing the collaboration with cross-functional stakeholders to ensure regulatory compliance is met. The 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
- 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
- Strong Project management skills
- 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
- 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
- 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.
-
Regulatory Affairs Director
6 days ago
Los Angeles, California, United States CPS Inc Full timeJob SummaryCPS Inc. is seeking a highly experienced and skilled Director of Regulatory Affairs to lead our regulatory efforts and ensure compliance with all relevant laws and regulations.Key ResponsibilitiesRegulatory Leadership: Provide strategic guidance on regulatory matters, identify and mitigate risks, and ensure compliance with all relevant laws and...
-
Lead Regulatory Affairs Manager
2 weeks ago
Los Angeles, California, United States Identified Talent Solutions Full timeJob Title: Senior Manager, Regulatory Strategy Location: Azusa, CA Position Type: Full-time We are excited to present a remarkable opportunity within a forward-thinking Cosmetics organization dedicated to excellence and ongoing enhancement across all business facets, particularly in Quality Control and Regulatory Affairs. As the organization expands its...
-
Lead Regulatory Affairs Manager
2 weeks ago
Los Angeles, California, United States Identified Talent Solutions Full timeJob OverviewPosition Title: Senior Manager, Regulatory StrategyLocation: Azusa, CAEmployment Type: Full-timeWe are excited to present an exceptional opportunity within a forward-thinking Cosmetics organization that prioritizes excellence and ongoing enhancement in all facets of operations, particularly in Quality Control and Regulatory Affairs. As the...
-
Head of CMC Regulatory Affairs
2 weeks ago
Los Angeles, California, United States BioPhase Solutions Full timePosition OverviewBioPhase Solutions is dedicated to connecting exceptional talent with leading organizations in Southern California's scientific sector. We are currently seeking a Director/Sr. Director, CMC Regulatory Affairs for a prominent biotechnology firm in the Greater Los Angeles region.The Director/Sr. Director, CMC Regulatory Affairs will spearhead...
-
Regulatory Affairs Director
1 day ago
Los Angeles, California, United States CPS, Inc. (Food & Beverage Division) Full timeAbout the RoleCPS, Inc. (Food & Beverage Division) is seeking a highly skilled and experienced Regulatory Affairs Director to join our team. As a key member of our organization, you will play a critical role in ensuring compliance with U.S. and international regulations, while driving innovation and growth in our industry.Key ResponsibilitiesRegulatory...
-
Food Regulatory Affairs Specialist
2 weeks ago
Los Angeles, California, United States Michael Page Full timeCompany OverviewOur client is a leading manufacturer specializing in high-quality beverages and protein bars, renowned for its innovative approach and commitment to excellence.Role OverviewWe are seeking a dedicated Regulatory Manager to oversee and direct all regulatory initiatives within the organization.Key ResponsibilitiesEnsure compliance of all...
-
Regulatory Affairs Specialist
2 weeks ago
Los Angeles, California, United States Abbott Full timeAbout AbbottAbbott is a leading global healthcare organization dedicated to enhancing health outcomes across various life stages. Our diverse portfolio includes innovative technologies in diagnostics, medical devices, nutritionals, and branded generic medicines. With a workforce of 114,000 professionals, we serve individuals in over 160 countries.Working at...
-
Regulatory Affairs Specialist
3 days ago
Los Angeles, California, United States Kindeva Drug Delivery Company Full timeJob SummaryKindeva Drug Delivery Company is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with global regulatory requirements and providing strategic planning for regulatory changes.Key ResponsibilitiesManage regulatory compliance activities for...
-
Regulatory Affairs Specialist
2 weeks ago
Los Angeles, California, United States Abbott Full timeAbout AbbottAbbott is a prominent global healthcare organization dedicated to enhancing health and well-being across all life stages. Our extensive portfolio includes transformative technologies that span diagnostics, medical devices, nutritionals, and branded generic medicines. With a workforce of 114,000, we serve individuals in over 160 countries.Position...
-
Los Angeles, California, United States SprintRay Inc. Full timeCompany Overview:SprintRay Inc. is a dynamic organization committed to innovation and excellence in the realm of 3D printing technology. We foster a collaborative environment where creative minds come together to tackle complex challenges.Position Summary:We are currently in search of a dedicated Regulatory Affairs and Quality Assurance Specialist to join...
-
Regulatory Affairs Operations Coordinator II
2 weeks ago
Los Angeles, California, United States Abbott Full timeCompany Overview:Abbott is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their health journey. Our extensive portfolio includes innovative technologies across diagnostics, medical devices, nutrition, and branded generic medicines.With a workforce of 114,000 employees, we are committed to...
-
Quality Assurance and Regulatory Affairs Expert
2 weeks ago
Los Angeles, California, United States SprintRay Inc. Full timeCompany Overview:SprintRay Inc. is a dynamic organization committed to innovation and excellence in the field of 3D printing technology. We foster a collaborative environment where talented individuals can explore creative solutions to complex challenges.Position Summary:We are currently seeking a dedicated Regulatory Affairs and Quality Assurance Specialist...
-
Regulatory Affairs Specialist
3 days ago
Los Angeles, California, United States BioPhase Solutions Full timeJob OverviewBioPhase Solutions is seeking a highly skilled Regulatory Affairs Associate to join our team. As a key member of our cross-functional team, you will play a critical role in ensuring the commercialization of food, food supplements, dietetic products, energy drinks, and personal care products in the regions of responsibility.Key...
-
Associate Governmental Program Analyst
3 days ago
Los Angeles, California, United States Department of Consumer Affairs Full timeJob SummaryThe Department of Consumer Affairs is seeking a highly skilled Associate Governmental Program Analyst to join our team. As a key member of our Probation Unit, you will be responsible for monitoring a caseload of licensees who are placed on probation, reviewing and analyzing documents submitted by probationers, and identifying and referring...
-
Lead Manager, Regulatory Compliance Strategy
2 weeks ago
Los Angeles, California, United States Identified Talent Solutions Full timeJob OverviewPosition Title: Senior Manager, Regulatory StrategyLocation: Azusa, CAEmployment Type: Full-timeWe are excited to present an exceptional opportunity with a forward-thinking Cosmetics organization. The team is dedicated to excellence and continuous enhancement across all business facets, particularly in Quality Control and Regulatory Affairs. As...
-
Government Affairs Director
4 days ago
Los Angeles, California, United States metropolis Full timeAbout the RoleMetropolis is seeking a seasoned Government Affairs professional to lead our government relations efforts and shape the company's strategy for engaging governments and community leaders.This is a unique opportunity to join a cutting-edge company at the forefront of innovation in the parking and mobility space.Key ResponsibilitiesDevelop and...
-
VP, Public Affairs
3 weeks ago
Los Angeles, California, United States Metropolis Technologies Full timeMetropolis develops advanced computer vision and machine learning technology that makes mobile commerce remarkable. Our platform is already deployed in hundreds of mobility facilities and industries with billions in opportunity. We're building the digital pipes through which the future of mobile commerce will move.The Head of Public Affairs is responsible...
-
Los Angeles, California, United States Sequence Systems Full timeSenior Consultant / Group Leader – Energy and Utility Economics & PolicySequence Systems is seeking a seasoned professional to join our team as a Senior Consultant, focusing on Energy and Utility Economics and Policy. This role is pivotal in our efforts to enhance our consulting practice, which specializes in the intricate analysis of economic,...
-
Head of Regulatory Compliance
4 days ago
Los Angeles, California, United States CPS Inc Full timeDirector of Regulatory Affairs - West CoastDirector of Regulatory Affairs – West CoastThe Director of Regulatory Affairs at CPS, Inc. will act as the principal authority in Scientific & Regulatory Affairs, managing all aspects of U.S. and international regulations (including EU, CAN, AUS, and others), as well as overseeing third-party certifications for...
-
Head of Regulatory Compliance
3 days ago
Los Angeles, California, United States CPS Inc Full timeDirector of Regulatory Affairs - West CoastDirector of Regulatory Affairs – West CoastThe Director of Regulatory Affairs at CPS, Inc. will act as the foremost authority in Scientific & Regulatory Affairs, managing all aspects of U.S. and international regulations (including EU, CAN, AUS, and others), as well as overseeing third-party certifications for our...
