Vice President, Regulatory Affairs and Quality Assurance
About the Company
Innovative AI company providing life-saving technology to healthcare organizations
Industry
Medical Devices
Type
Privately Held, VC-backed
Founded
2011
Employees
201-500
Funding
$76-$100 million
Categories
Specialties
About the Role
The Company is seeking a Vice President of Regulatory Affairs and Quality Assurance to lead the strategic and operational management of quality and regulatory activities. The successful candidate will be responsible for developing and maintaining the company's regulatory affairs and quality assurance strategy and programs, ensuring compliance with global regulatory requirements, and driving a culture of quality throughout the organization. This role involves establishing and monitoring quality standards, metrics, and objectives, as well as leading process improvements to support the company's growth objectives. The VP will also be the key contact for building and managing relationships with regulatory agencies and standards groups, and will be expected to have a commercial focus in the application of regulatory requirements. Candidates for the VP RA/QA position at the company should have a Bachelor's degree in a relevant engineering or scientific discipline, with an advanced degree strongly preferred, and at least 15 years of progressive experience in leading RA/QA, with a primary focus on QA and a background in SaMD, SaaS, SWMD models, and software-focused quality systems. The role requires a leader who is analytical, results-oriented, and process-driven, with a passion for quality and regulatory compliance. Excellent knowledge of US and global regulatory frameworks, direct experience with submissions, and a proven track record of leading engagements with regulatory agencies are essential. The ideal candidate will have outstanding communication skills, strong problem-solving abilities, and a demonstrated capacity to manage and prioritize multiple projects and teams.
Hiring Manager Title
Regulatory Affairs Project Manager
Travel Percent
20%
Functions
...\t\n Ardor Health Solutions is looking for a Utilization Review/Quality Assurance - UR/QA to join our travel team in Kealakekua... ...09/22/2025\n \n\n Benefits include: \n\n \n\t ~ Major Medical \n\t ~ Dental/Vision Insurance \n\t ~ Pet Insurance \n\t...
...Job Description Job Description Job Requirements: Minimum 5 years experience in Fleet or Transportation field. Knowledge of DOT and state inspection programs. Background in heavy vehicle repair along with 3-5 years of supervisory experience. Excellent Organizational...
...this is your opportunity to thrive. What Youll Do: As an Associate Account Executive , youll enter our comprehensive B2B Sales Training Program, designed to set you up for success in selling consulting and professional services. Target Key Accounts:...
...background in contract administration and project management. While experience in these... ...timelines, budgets, and quality standards. Coordinate with internal and external stakeholders,... ...skills, with the ability to work collaboratively in a team environment....
Description The Work From Home Data Entry Clerk is a vital role within our Learning & Development team. As a fully remote position, this role requires a detail-oriented individual who can manage data entry tasks efficiently from the comfort of their own home. The successful...