Quest Diagnostics · 3 months ago
Senior Specialist, Regulatory Affairs
San Juan Capistrano, CA
Full-time
Onsite
Mid, Senior Level
$90K/yr - $130K/yr
3+ years expQuest Diagnostics is a leading provider of diagnostic information services, and they are seeking a Senior Specialist in Regulatory Affairs. This role involves providing regulatory guidance throughout the product development cycle, ensuring compliance with regulations, and managing submissions to regulatory agencies.
BiotechnologyHealth CareHealth DiagnosticsInformation ServicesPrecision Medicine
No H1B
Responsibilities
Provide regulatory guidance in product design, clinical studies, market authorization strategies, and labeling
Review and edit product submissions and other communications prepared by junior department members
Act as regulatory subject matter expert for junior department members
Provide pre-market and post-market regulatory strategy to ensure regulatory compliance and advance commercial objectives
Represent Regulatory on core teams providing regulatory feedback and guidance throughout the product development cycle and coordinating team inputs for submissions
Prepare global regulatory applications, as well as internal regulatory file documentation
Manage submissions such as US FDA Section 510(k) Notifications, Pre-market Approval (PMA) Applications and Supplements, EU IVDR, Technical Documentation, ROW submissions and global product registrations
Independently communicate with regulatory agencies on pre-market and post-market related issues
Document, consolidate and maintain oral and written communications with regulatory bodies like FDA, Health Canada, notified bodies, etc
Participate in training and education seminars as appropriate to learn regulatory requirements and keep abreast of current regulatory trends
Monitor proposed regulatory changes from the FDA and worldwide regulatory authorities and provide management with impact of changes in the Regulatory environment
Review related regulatory publications and documents to stay informed about current regulatory actions
Interface with industry associations to help state, federal, and international regulatory agencies develop regulations
Provide back up to the Regulatory Affairs Director as needed
Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees. You also have a responsibility to cooperate in all safety or health-related programs and assist in solving safety and health problems. Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process
Perform other duties as assigned. Provide technical and editorial direction to junior department members
Qualification
Required
BS/MS in Biology, Immunology, Microbiology, Biochemistry, Medical Technology or related discipline required
Must have extensive knowledge of U.S, Canadian, European and other International In vitro diagnostic regulations and standards
At least three to five years of pre-market regulatory experience in IVD industry
Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required
Must be able to work well in team environment with individuals from diverse functional areas, as well as work independently
Must demonstrate leadership skills without having direct authority
Must have experience working on project/product from concept to market introduction
Must have proven analytical capabilities, solid understanding of manufacturing and change control, and awareness of regulatory trends
Must have experience in negotiation of technical issues with internal and external functions including health authorities
Preferred
US-RAC preferred but not required
Benefits
Medical/Prescription Drugs
Dental
Vision
Flexible Spending Accounts (FSAs)
Supplemental Health Plans
401(k) Plan – Company match dollar-for-dollar up to 5%
Employee Stock Purchase Plan (ESPP)
Supplemental Life Insurance
Dependent Life Insurance
Short- and Long-Term Disability buy-up
Blueprint for Wellness
Emotional Well-Being Resources
Educational Assistance
Paid time off / Health Time
Variable Compensation Plans
Sales Incentive Plans
Company
Quest Diagnostics
Quest Diagnostics is a clinical laboratory that offers diagnostic testing, services, and information.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$2.6B2024-08-15Post Ipo Debt· $1.85B
2023-10-30Post Ipo Debt· $750M
1996-12-17IPO
Leadership Team
James Davis
Chief Executive Officer and President
Cecilia McKenney
SVP & Chief Human Resources Officer
Recent News
2026-01-09
Company data provided by crunchbase