Regulatory Affairs Manager Jobs in the United States
Dentsply Sirona
Charlotte, NC
Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.
Daiichi Sankyo, Inc.
Bernards, NJ
Acting as QA point person for assigned programs, the Manager collaborates with GxP Quality representatives (Development QA, Audits & Compliance, Quality Management System (QMS) QA including Vendor Quality, Pharmacovigilance QA and provides guidance during the development and execution of Corrective and Preventive Actions (CAPAs), including tracking timely closure, effectiveness checks, and escalation of critical issues. Serve as a key liaison to support audits and inspections as applicable Cross-functional and Global Team Participation: Participate in the review of quality and compliance topics, including KQI, at Quality Governance Meetings, in close alignment with DS QA teams (DSJ, DSI, DSE, DSBR) to proactively identify potential risks and opportunities for continuous improvement.
ProKatchers
Columbus, OH
5-7 years in a regulated nutritional food-manufacturing environment, preferably pediatric or medical nutrition products, in a Quality, R&D, Project Management, Procurement or Operations function and good knowledge of food GxP and nutritional regulations. Bachelor’s degree in a relevant discipline/or equivalent work experience is required (Business Administration, Chemistry, Microbiology, Food Science, Engineering).
Aquestive Therapeutics
Warren, NJ
This individual serves as the regulatory affairs main contact to project teams, providing leadership across functions for regulatory strategic planning and execution related to achieving program milestones. Oversees the day-to-day operations within the regulatory affairs function including oversight of submission coordination, submission publishing, advertising/promotional review, and process development/improvement initiatives.
Waters Corporation
San Diego, CA
Experience in management of clinical and laboratory-based teams, leading teams remotely and managing projects effectively across geographical sites. • Develop and manage the Clinical Affairs team in support of clinical site selection, study design and execution of clinical trials and analytical validation studies to support regulatory and commercial goals.
Daiichi Sankyo, Inc.
Bernards, NJ
The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development to post-approval phase for biological, Cell and Gene Therapy, small molecule, Vaccines, and/or siRNA drug projects consistent with the company goals. Digital Transformation Responsibilities: The Associate Director, Digital Transformation (within Regulatory CMC), will serve as a strategic leader and change agent driving the organization's transition toward structured CMC data and next-generation digital capabilities.
CSL Behring
King of Prussia, PA
We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
CSL Behring
King of Prussia, PA
You are a member of the respective GRA GRS Therapeutic Area and contributes to the vision and goals of CSL as: Regulatory leaders who leverage regional regulatory experience / expertise to influence and actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure ‘One GRA Voice’, effective inputs into risk assessment and decision making.
Flagstar Bank
$84878 - $112463
Rockville Centre, NY
Reviews various reports including check fraud, significant activity, significant change, large deposit, detailed transaction report and month-end reports; investigate & approve when needed. Develops and expands existing relationships including sales efforts; engages key Product Partners as appropriate in delivering the full breadth of the bank to satisfy clients needs.
Constellation Energy
$152100 - $169000
Warrenville, IL
Understands interrelations and functions of various organizations (e.g., Nuclear Regulatory Commission (NRC), Institute of Nuclear Power Operators (INPO), Nuclear Energy Institute (NEI), North American Electric Reliability Corporation (NERC) etc.) related to nuclear power. Perform independent and in-depth research, reviews, studies and analyses to develop, manage and implement regulatory activities, related to plant safety, reliability, maintainability, and availability ensuring compliance to site's needs, regulatory requirements, and corporate policies.
Fast Pace Health
Clarksville, TN
Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
Fast Pace Health
Mermentau, LA
Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
First Horizon Bank
Metairie, LA
Headquartered in Memphis, TN, the banking subsidiary First Horizon Bank operates in 12 states across the southern U.S. The Company and its subsidiaries offer commercial, private banking, consumer, small business, wealth and trust management, retail brokerage, capital markets, fixed income, and mortgage banking services. First Horizon Corporation is a leading regional financial services company, dedicated to helping our clients, communities and associates unlock their full potential with capital and counsel.
First Horizon Bank
Nashville, TN
Headquartered in Memphis, TN, the banking subsidiary First Horizon Bank operates in 12 states across the southern U.S. The Company and its subsidiaries offer commercial, private banking, consumer, small business, wealth and trust management, retail brokerage, capital markets, fixed income, and mortgage banking services. First Horizon Corporation is a leading regional financial services company, dedicated to helping our clients, communities and associates unlock their full potential with capital and counsel.
Align Technology, Inc.
San Jose, CA
Partnering with cross-functional teams (such as R&D, Marketing, etc.), as well as internal and external customers, you’ll help lead and manage projects to ensure clinical studies and activities are executed in accordance with applicable regulations and that the quality of clinical data generated from clinical trials or limited release meets the regulatory requirements for approval. • Define project scope, develop timelines and budgets, and assemble the study team clinical affairs activities (including but not limited to clinical studies, limited releases, focus groups, data collection activities, etc) .
SOFIE
$90000 - $100000
Totowa, NJ
The successful candidate will provide quality assurance management, decision making, and support to the RCM group with specific emphasis on change control, corrective and preventive actions, procedure approval, exception reporting, partner/sponsor communications, validation and qualification reviews, and review and approval of various other documents and reports applicable to new products. This includes making quality related decisions and assisting in the generation, review, and approval of change controls, corrective and preventive actions, procedures, exception reports, protocols, and other documents applicable to new products.
VNS Health
$85000 - $106300
New York, NY
Minimum two years of clinical assessment, homecare or hospital experience requiredExcellent organizational and time management skills, interpersonal skills, verbal and written communication skills requiredDemonstrated strong relationship management skills, including a high degree of psychological sophistication and non-aggressive assertiveness requiredDemonstrated successful conflict management skills and negotiation of “win-win” solutions requiredWorking knowledge of Microsoft Excel, Power-Point, and Word requiredKnowledge of Medicaid and/or Medicare regulations requiredWorking Knowledge of UAS-NY preferred . Powered and informed by data analytics that are unmatched in the home and community-health industry, VNS Health offers a full range of health care services, solutions and health plans designed to simplify the health care experience and meet the diverse and complex needs of the communities and people we serve in New York and beyond.
Medline Industries - Transportation & Operations
Chicago, IL
Knowledge and understanding of FDA product codes and product class structure, Quality Management Systems and Good Manufacturing Practices, or willingness to learn through training and independent research. - Train and mentor new employees, divisional QA's and product managers on regulatory product structure, regulatory labeling requirements, and Medline labeling procedure(s).
DLA Piper LLP (US)
$168478 - $272949
Seattle, WA
While the specific job requirements of a DLA Piper position may vary depending upon scope of the job and area of specialty, there are certain universal requirements that are expected of all DLA Piper employees, which include but are not limited to: Effectively communicate, verbally and in writing, with clients, lawyers, business professionals, and third parties. Prior substantive legal experience in one or more of the practice's subgroups, including Data Protection, Privacy & Security; Environmental; FDA Regulatory; Financial Regulatory & Technology; Government Affairs & Public Policy; Government Contracts; Healthcare Regulatory; National Security & Global Trade; Telecom; and Transportation Regulatory.
Hawaiian Electric Industries
Honolulu, HI
Manages the end-to-end process including complex regulatory approvals, land/Right-of-Way acquisition, public relations management, or cross-functional/multi-level (internal) management from conceptualization/ inception through budgeting, design, approval, procurement, construction, placement in operation, and project closing. o Works with and through community groups, neighborhood boards, government agencies, the media, other utilities and private companies, the City Council, the State Legislature, and the PUC to disseminate information, address concerns, obtain permits and approvals, and resolve project-related problems.
Pyramid Consulting, Inc
$50 - $55
Foster City, CA
By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Immediate need for a talented Medical Information Manager / MLR Review Specialist (Veeva, Oncology, Pharma) .
Medline Industries - Transportation & Operations
Northfield, IL
Some of the activities for the manager will include negotiating supplier price reductions and analyzing geo-political risks, resolving price and cost disagreements with vendors, coordination with supply chain, quality, and overseas offices, and overseeing vendor relationships. Manage an entire divisional portfolio of managed categories leveraging sourcing experience to drive continuous improvement across all Category Managers with the goal to contain costs, drive improved raw material consumption, and other-cost down initiatives.
Circle
$235000 - $290000
San Francisco, CA
Circle’s platform includes the world’s largest regulated stablecoin network anchored by USDC, Circle Payments Network for global money movement, and Arc, an enterprise-grade blockchain designed to become the Economic OS for the internet. This role sits at the center of Circle’s engagement with the largest, most complex financial institutions in the world and is critical to advancing USDC’s role in regulated payments, liquidity, treasury, and emerging on-chain financial infrastructure.
VNS Health
$85000 - $106300
New York, NY
Powered and informed by data analytics that are unmatched in the home and community-health industry, VNS Health offers a full range of health care services, solutions and health plans designed to simplify the health care experience and meet the diverse and complex needs of the communities and people we serve in New York and beyond. • Performs in-home assessment for members who have identified significant changes in condition since last in-home assessment; provides comprehensive review and determination of member’s needs, including completion of UAS assessment questionnaire, tasking tool, and a projected service plan.
Company Confidential
$75000 - $95000
RENTON, WA
We are seeking a Compliance & Legal Affairs Manager to oversee regulatory compliance, contract review, and risk management across all areas of our operations. Identify legal and business risks; propose practical mitigation strategies.
Fast Pace Health
Roanoke, LA
Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
Fast Pace Health
Coffeeville, MS
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. Posting Title: Family Nurse Practitioner Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Fast Pace Health
Garfield, KY
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. Posting Title: Family Nurse Practitioner Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Fast Pace Health
Spring Hill, TN
Posting Title: Family Nurse Practitioner/Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
Fast Pace Health
Irvington, KY
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. Posting Title: Family Nurse Practitioner Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Fast Pace Health
Salem, IN
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. The ability to maintain friendly, cordial relations with all clients and employees; maintain a positive work atmosphere by acting and communicating in a manner that results in a positive work relationship with customers, co-workers and managers.
Fast Pace Health
Horse Branch, KY
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. The ability to maintain friendly, cordial relations with all clients and employees; maintain a positive work atmosphere by acting and communicating in a manner that results in a positive work relationship with customers, co-workers and managers.
Fast Pace Health
Henderson, NC
Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
Fast Pace Health
Salem, IN
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. The ability to maintain friendly, cordial relations with all clients and employees; maintain a positive work atmosphere by acting and communicating in a manner that results in a positive work relationship with customers, co-workers and managers.
Fast Pace Health
Morgan City, LA
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. Posting Title: Family Nurse Practitioner - FLOAT Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Snf Holding Company
Riceboro, GA
While the Integrated Management System (IMS) is owned by the Responsible Care® organization, this role serves as a critical Quality partner, responsible for quality investigations, customer complaints, CAPA effectiveness, performance metrics, and IMS audit execution. The Senior Quality Manager provides senior-level leadership and hands-on support to Quality teams across one large manufacturing site and multiple smaller sites.
Grid United
Houston, TX
Established in 2021 by proven industry leaders, Grid United is developing utility-scale electric multi-state transmission projects that will provide long-term economic benefits to communities across the country, provide Americans with improved grid resiliency for our homes and businesses, and cost savings for electricity consumers. Grid United is a mission-driven company aiming to solve the largest barrier to a more reliable, resilient and affordable grid by developing new long haul electric transmission lines in the United States.
BIO RAD LABORATORIES - 390
$116100 - $159600
Seattle, WA
This role represents Clinical Affairs collaborates cross-functionally with Regulatory Affairs, R&D, Quality, Marketing, and external partners to deliver high-quality clinical data and evidence supporting product registration and commercialization of Bio-Rad diagnostic products. Work Experience: 5 years' (3 years' with advanced degree) experience in clinical research with at least 3 years of clinical trials execution role, preferably in an IVD company; and 1 year of people management experience.
Cerapedics Inc
$130000 - $140000
Westminster, CO
Develop, author, assemble, publish and submit IDE Annual Reports, Post-Approval Study Annual Reports, and PMA Annual Reports, ensuring timely submission in accordance with FDA Approvals. As a Regulatory Affairs Manager working on the Regulatory Affairs team, you will be empowered through meaningful work and career development to coordinate closely with cross-functional partners and others on the development, submission, and prosecution of Regulatory filings.
CSL Behring
King of Prussia, PA
Products is responsible for: Partnering closely with CSL’s R&D, Manufacturing, Quality, Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving CMC regulatory and compliance requirements for the assigned product portfolio. Ensures Accountability: Follows through on commitments and makes sure others do the same; Acts with a clear sense of ownership; Takes personal responsibility for decisions, actions, and failures; Establishes clear responsibilities and processes for monitoring work and measuring results; Designs feedback loops into work.
U.S. Renal Care
Waterville, OH
Additionally, if the nursing requirements listed below are not met, an individual may be placed in the Administrator role without them; however, in the absence of these qualifications, there must be a designated Registered Supervising Nurse at the clinic who does possess these qualifications: Must be full-time employee of the Company and available to clinic staff during time clinic is open. · Continuously monitor to ensure that a safe and sanitary physical environment is maintained throughout the facility; that all equipment is maintained and functions properly; and that adequate and appropriate inventory levels of all supplies are available and used correctly.
U.S. Renal Care
Waterville, OH
Additionally, if the nursing requirements listed below are not met, an individual may be placed in the Administrator role without them; however, in the absence of these qualifications, there must be a designated Registered Supervising Nurse at the clinic who does possess these qualifications: Must be full-time employee of the Company and available to clinic staff during time clinic is open. · Continuously monitor to ensure that a safe and sanitary physical environment is maintained throughout the facility; that all equipment is maintained and functions properly; and that adequate and appropriate inventory levels of all supplies are available and used correctly.
Werfen
$95000 - $170000
San Diego, California
Teamwork: Coordinate with department leadership and other cross-functional areas including R&D, Project Management, Marketing, Quality Engineering, Manufacturing, and Quality Assurance to establish priorities and goals for design and development projects, product changes, international product registrations, review of Advertising & Promotional Materials, etc. On-Market Support (Sustaining): Provide leadership, guidance and assistance to the Regulatory Affairs team in the regulatory impact assessments of changes on existing Market Authorizations that include but are not limited to design changes, changes to product composition, manufacturing processes, and the labeling of products.
Changent
$88000 - $100000
Denver, CO
The position focuses on federal program implementation and regulatory analysis tied to initiatives, such as the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program and the Family First Prevention Services Act. The Regulatory Affairs Manager advances the work of Changent to strengthen the systems and partnerships that support maternal, infant, and early childhood health.