Regulatory Affairs Associate
Abbott
Title: Regulatory Affairs Associate Location: Santa Clara, California Duration: 12 Months
100% Onsite Summary
100% Onsite Summary
- 5+ years of experience in Regulatory Affairs
- Hands-on experience with regulatory labeling, specifically addendum labeling, supplemental labeling, and/or execution of labeling changes
- Demonstrated familiarity with regulated medical device environments and quality systems.
- Given the nature of the work, it's important that candidates are seasoned and can operate with minimal ramp-up.
- Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
- Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
- Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices.
- Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements;
- knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals.
- Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected.
- Typically reports to a manager or head of a unit/department.
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account (for High-Deductible Health Plans)
- Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
- Supplemental Life Insurance
- Short Term Disability (coverage varies by state)
- Long Term Disability
- Critical Illness, Hospital coverage, Accident Insurance
- MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
- 401(k)
- Published on 26 May 2026, 1:17 PM
Vacancy posted 19 hours ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Associate in Lakeside, CA vacancy
$48.1k - $98k
...~ Ability to perform shift work ~ Secret clearance ~ HS diploma or GED and 6+ years of experience with program management, Associate's degree and 4+ years of experience with program management, or Bachelor's degree and 2+ years of experience with program management...SuggestedFull timeContract workPart timeWork at officeLocal areaRemote workShift workBOOZ, ALLEN & HAMILTON, INC.
El Cajon, CA4 days ago- The City of Santee is seeking a Plans Examiner to review and apply building code standards for various construction projects. The role includes responsibilities such as examining plans for compliance, assisting customers at the public counter, and coordinating with other...SuggestedRemote work
- ...while also overseeing provider credentialing processes to ensure regulatory compliance and organizational excellence. Job Purpose:... ...Specifications: Education and Experience: ~ Essential: Associate's Degree in Business Administration or equivalent experience or...Suggested
Sycuan
El Cajon, CA1 day ago $61.9k - $141k
Data Analyst The Opportunity: As data analyst, you love diving into data and turning it into meaningful insights. With the abundance of structured and unstructured data, you understand the importance of transforming complex data sets into useful information to solve...SuggestedFull timeContract workPart timeWork at officeLocal areaRemote workBooz Allen Hamilton
El Cajon, CA3 days ago- McAlister Institute in El Cajon, California is seeking a Billing Clerk to ensure accurate and compliant billing operations. This role requires at least 2 years of administrative support experience, attention to detail, and excellent organizational skills. Responsibilities...Suggested
$75k - $90k
A faith-based nonprofit organization is seeking a Business Analyst to support decision-making through data analysis and reporting. This role includes gathering business requirements, building dashboards, and providing actionable insights to improve operational effectiveness...Full time$113k - $155.65k
Johnson Outdoors is seeking a Finance Manager to manage accounting and finance functions at their El Cajon location. The role includes overseeing multi-currency financial reporting, conducting financial analysis, and coordinating audits to ensure compliance. You will work...Temporary work- ...provides expert-level support for DFARS Business System compliance across a broad scope of activities, including audit readiness, regulatory compliance initiatives, and complex special projects. The role serves as a trusted advisor to DFARS Business System stakeholders...Full timeFor contractorsWork at officeRemote work
- A manufacturing company in El Cajon, CA is seeking an EH&S Coordinator to provide plant-level support for environmental, health, and safety activities. Responsibilities include conducting safety training, auditing safety compliance, and investigating incidents. Candidates...
$40.79 - $51.01 per hour
Grossmont/Cuyamaca Community College District in El Cajon, CA, is seeking an Information Systems Business Analyst to manage ERP systems, understand academic and business operations, and analyze user requirements. The position demands a Bachelor's degree and five years of...Hourly payFull time- Position Summary We are seeking an experienced, hands-on Project Manager to join our aerospace forging operation during a critical period of commercial growth. This role is accountable for leading production ramp-up and rate-readiness initiatives—aligning people, ...
Precision Metal Products, Inc.
El Cajon, CA2 days ago - Job Description Job Description At TURN our mission is Improving Lives. Our organization embraces the tenets of client-centered care, and our core values People, Culture and Growth are at the forefront of everything we do. We hire exceptional individuals seeking ...Contract workWork at officeShift work
MENTAL HEALTH SYSTEMS INC
Santee, CAa month ago - Job Description Job Description Description: Join McAlister Institute, a 48-year beacon in San Diego's Recovery Community. We are seeking a Peer Support Specialist who will play a crucial role in providing support and advocacy for individuals navigating their...Contract workWork at officeLocal areaTrial periodFree visa
McAlister Institute for Treatment & Education,Inc.
El Cajon, CA2 days ago $113k - $155.65k
Johnson Outdoors Inc. is seeking a Finance Manager to oversee financial operations in El Cajon, California. This temporary role involves managing multi-currency financial reporting, conducting financial analysis, and ensuring compliance with regulations. The ideal candidate...Contract workTemporary work$40.79 - $51.01 per hour
...color, disability, gender, gender identity, gender expression, nationality, race or ethnicity, religion, sex, sexual orientation, or association with a person or a group with one or more of these actual or perceived characteristics. The district encourages candidates who...Hourly payFull time- The Juris Agency in Santee, California is seeking an entry-level office manager to start a career in the insurance industry. This position prepares you for management roles by teaching you daily duties. You'll be responsible for onboarding agents, training new producers...Work at office
- Summary You will serve as a Combined Trades Supervisor II in the DEPARTMENT OF NAVY to include work sites of Portsmouth Naval Shipyard, Puget Sound Naval Shipyard, Norfolk Naval Shipyard, Trident Refit Facility Bangor, and Pearl Harbor Naval Shipyard and Intermediate...Permanent employmentFull timeTemporary workPart timeInterim roleWork at officeLocal areaImmediate startRemote workRelocationRelocation packageShift workNight shift
Department of the Navy - Agency Wide
El Cajon, CA4 days ago - St. Paul's PACE in El Cajon is seeking a Home Care Coordinator to perform in-home safety evaluations and manage care delivery for elderly participants. This role involves conducting assessments, coordinating services, and ensuring compliance with care guidelines. Candidates...Flexible hours
- ...) , U.S. Army Corps of Engineers (USACE), National Park Service (NPS), Bureau of Reclamation (BOR), and the Department of Veterans Affairs (VA). The Project Manager will oversee all phases of construction, renovation, and repair projects, typically up to $20,000,000, ensuring...Contract workFor subcontractorWork at office
Fedvet Construction
El Cajon, CA26 days ago $113k - $155.65k
Description Want a chance to represent an exceptional outdoor brand? Join our Team! SCUBAPRO , a global market leader in innovative diving products, creates amazing outdoor experiences . For over 60 years, our exceptional gear has given people the opportunity...Temporary workWork at officeJohnson Outdoors
El Cajon, CA3 days ago- Now Hiring: Experienced HVAC Commercial Project Manager Location: Santee, CA. Full-Time. Competitive Pay. Great Benefits. Are you a seasoned HVAC Commercial Project Manager ready to take on exciting, large-scale projects with a top-tier team? We’re looking for a driven...Full timeFor subcontractorImmediate start
$85k - $125k
...clients, peers, subcontractors, permitting jurisdictions, and utility providers. Responsible for job safety, quality, schedule, and regulatory compliance required daily on construction site(s) or project offices. Travel extended days when required by site location. Build...For subcontractorWork at office- Summary Corrections professionals who foster a humane and secure environment and ensure public safety by preparing individuals for successful reentry into our communities. Duties Provides supervision, care and correctional treatment of inmates and guidance...Local areaRelocation packageFlexible hoursShift work
Federal Bureau of Prisons
El Cajon, CA2 days ago - ...recruiting and onboarding project staff as needed. Operational Excellence Ensure adherence to company policies, safety procedures, and regulatory compliance. Implement project controls, quality assurance, and reporting standards. Identify opportunities to improve project...Full timeFor contractorsFor subcontractorVisa sponsorship
$25 - $27 per hour
Overview Outpatient MAT Opioid Treatment Program (OTP) Seeking: Peer Support Specialist ~ Required: Medi-Cal Peer Support Specialist (CMPSS) Full Time Schedule: Monday - Friday, 5:30 AM - 2:00 PM Our Benefits: Semi-Annual Bonus Program Medical...Hourly payFull timeWork experience placementInternshipWork at officeLocal areaMonday to FridayEarly shiftAcadia Healthcare
El Cajon, CA1 day ago- Under the general direction of the Deputy Director of Behavioral Health, or designee, plans, organizes, supervises, and participates in the operational and program activities of the Substance Use Disorders (SUD) Intervention Programs as part of the Behavioral Health Division...
$95k - $125k
About Us We are a leader in fully-integrated electrical and building systems installations, with capabilities ranging from complete pre-construction and new construction to renovation and maintenance for a variety of markets. Our team is prepared to handle a wide range ...Contract workFor contractorsFor subcontractorWork at officeFlexible hours$18.4 - $18.9 per hour
...the Store when functioning as the Manager on Duty. Area Supervisors are responsible for opening and closing the Store, supervising Associates, and maintaining a friendly, easy to shop environment. They ensure proper merchandise presentation, and maintain a clean work...Work at officeLocal areaImmediate startShift workWeekend workAfternoon shiftRoss Stores, Inc.
Lakeside, CA2 days ago- ...Position Summary The Project Support Associate provides essential administrative, operational, and cross-functional support across front-end reception functions and key internal departments including Human Resources, Accounting, and Payroll. This role plays a critical...Work at office
FLORES
Santee, CA4 days ago - Job Summary General Atomics (GA), and its affiliated companies, is one of the world’s leading resources for high-technology systems development ranging from the nuclear fuel cycle to remotely piloted aircraft, airborne sensors, and advanced electric, electronic, wireless...Hourly payFull timeWork at officeRemote work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Associate. Be the first to apply!
Related searches