Jobs
>
San Antonio

    Regulatory Affairs Manager - San Antonio, United States - Extremity Care

    Extremity Care
    Extremity Care San Antonio, United States

    2 weeks ago

    Default job background
    Description
    Job Description


    Job Description Salary:
    $90K


    Purpose:


    The Regulatory Affairs Manager is responsible for managing the regulatory affairs department and functions to ensure regulatory compliance of quality management system.


    Duties & Responsibilities:
    Review and approve audit agenda, plan, summary reports for internal audits.
    Facilitate and participate in external audits and collaborate with Quality Assurance Management to generate audit responses and associated CAPAs.
    Support FMEA of existing products and procedures.
    Initiate and investigate quality events.
    Manage and oversee supplier management program.
    Initiate and investigate quality Events.
    Perform FDA/AATB reportability determination for quality events.
    Review and approve quality events, ensuring appropriate investigation and CAPA.
    Author/revise procedures according to FDA, AATB, and other regulations (as appropriate).
    Manage submissions of FDA/AATB reportable events.
    Manage state license application submissions and renewals.
    Manage regulatory updates and evaluate needs for procedural changes to ensure compliance.
    Support and Collaborate with New Product Realization RA team.

    Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as appropriate), and industry standards.

    File and maintain records in accordance with standard operating procedures.
    Manage direct reports.
    Establish and monitor objective annual goals for direct reports.
    Conduct performance reviews and establish performance improvement plans as needed.
    Establish and execute continuing education strategy for department.
    Recruit, interview, and select personnel for hire.
    Attend/participate in offsite business

    meetings/conferences.
    Perform other related duties as assigned.
    Support cross functional Regulatory Affairs task when needed.


    Skills & Abilities:
    Extensive knowledge of applicable government regulations.
    Ability to inform and educate department heads on regulations and policies that require compliance.
    Excellent attention to detail and organizational skills
    Ability to multi-task
    Effective and verbal communication skills.
    Strong Leadership skills.


    Education & Experience:
    Bachelor's degree in a biological science or related field required.
    Master's degree preferred.
    At least 5 years of quality and/or regulatory experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field) with progressive management

    responsibilities/experience.

    #J-18808-Ljbffr
  • Extremity Care

    Regulatory Affairs Manager

    6 days ago

    Extremity Care San Antonio, United States

    Job Description · Job DescriptionSalary: $90K · Purpose: · The Regulatory Affairs Manager is responsible for managing the regulatory affairs department and functions to ensure regulatory compliance of quality management system. · Duties & Responsibilities: · Review and approve au ...

  • Valero Energy Corporation

    Manager Refinery Safety Affairs

    2 weeks ago

    Valero Energy Corporation San Antonio, United States

    Directs/assists the organization to ensure compliance with applicable Federal, State and Local safety, health and industrial hygiene regulations with a special emphasis for direct support of refinery safety efforts. Develops working relationships wit Manager, Refinery, Safety, Op ...

  • Valero Service

    Manager Refinery Safety Affairs

    2 weeks ago

    Valero Service San Antonio, United States

    **Description:** · Directs/assists the organization to ensure compliance with applicable Federal, State and Local safety, health and industrial hygiene regulations with a special emphasis for direct support of refinery safety efforts. Develops working relationships with operation ...

  • Extremity Care

    Regulatory Affairs Manager-Product Development

    2 weeks ago

    Extremity Care San Antonio, United States

    Job Description · Job Description Salary: $90K · Purpose: · The Regulatory Affairs Manager is responsible for managing the regulatory affairs for the product development department and functions to ensure regulatory compliance of quality management system, product realization an ...

  • Extremity Care

    Regulatory Affairs Manager-Product Development

    6 days ago

    Extremity Care San Antonio, United States

    Job Description · Job DescriptionSalary: $90K · Purpose: · The Regulatory Affairs Manager is responsible for managing the regulatory affairs for the product development department and functions to ensure regulatory compliance of quality management system, product realization and ...

  • The University of Texas at San Antonio

    Administrative Manager-Academic Affairs-Provost

    1 week ago

    The University of Texas at San Antonio San Antonio, United States

    · Administrative Manager-Academic Affairs-Provost · Location: San Antonio, TX · Regular/Temporary: Regular · Job ID: 11494 · Full/Part Time: Full Time · Org Marketing Statement · The University of Texas at San Antonio is a Tier One research university and a Hispanic Serving ...

  • University of Texas at San Antonio

    administrative manager-academic affairs-provost

    1 week ago

    University of Texas at San Antonio San Antonio, TX, United States

    Org Marketing Statement · The University of Texas at San Antonio is a Tier One research university and a Hispanic Serving Institution specializing in cybersecurity, health, fundamental futures, and social-economic transformation. With more than 34,300 students, it is the largest ...

  • Venergy Group LLC

    Project Manager Part Time

    5 days ago

    Venergy Group LLC San Antonio, United States Part time

    **SUMMARY/OVERVIEW** · This position is directly responsible for developing Request for Proposal (RFP) requirements and working collaboratively subcontractors, other Project Managers, and Site Superintendents. The Project Manager s (PM) job is to plan, budget, oversee, and docume ...

  • Aspire Medical Staffing

    Physician- Cardiovascular Electrophysiologist

    1 week ago

    Aspire Medical Staffing San Antonio, United States

    Aspire Medical Staffing is recruiting for a full-time permanent board certified/board eligible physician in Cardiac Electrophysiologists to provide services at the Audie L Murphy VA Medical Center. · Location: Audie L Murphy VA Medical Center, 7400 Merton Minter Street, San Anto ...

  • Evestra, Inc.

    Director of Regulatory Affairs

    1 week ago

    Evestra, Inc. San Antonio, United States

    Our Company: · Evestra, Inc. is an emerging biopharmaceutical company that focuses on developing and commercializing women's healthcare products. Based in San Antonio, Texas, Evestra's mission is to improve the health and well-being of women around the world through innovative te ...

  • University Health System

    Pharmacy Programs Manager

    1 week ago

    University Health System San Antonio, United States

    Full Time · 1055 Ada · Allied Health · Rotating Shifts · POSITION SUMMARY/RESPONSIBILITIES · Manages pharmaceutical supplies of the Pharmacy for neonatal through adult patients, subject to JCAHO, OSHA, Medicare/Medicaid standards and Texas State Board of Pharmacy Rules and Regula ...

  • Randstad North America, Inc.

    Manager, Quality Systems and Regulatory Compliance

    5 days ago

    Randstad North America, Inc. San Antonio, United States

    This position is responsible for the improvement, design, development, implementation and maintenance of the Gx. P Quality Management System (QMS) processes as relevant to cGMP Biomanufacturing. In addition, this position will also serve as an intern Manager, Compliance, Quality, ...

  • Randstad USA

    Manager, Quality Systems and Regulatory Compliance

    6 days ago

    Randstad USA San Antonio, United States Full time

    job summary: · This position is responsible for the improvement, design, development, implementation and maintenance of the GxP Quality Management System (QMS) processes as relevant to cGMP Biomanufacturing. In addition, this position will also serve as an internal Regulatory res ...

  • QTC Management, Inc.

    medical case specialist i-aww

    1 week ago

    QTC Management, Inc. San Antonio, TX, United States

    Are you someone who has a knack for details and a passion for helping others? If so, we would love to speak with you · Leidos QTC Health Services is seeking a Medical Case Specialist to support our Veteran Affairs Operations in San Antonio, TX. · Who is Leidos QTC Health Services ...

  • Microsoft Corporation

    Sr. Energy Regulatory Program Manager, Cloud Operations + Innovations

    1 week ago

    Microsoft Corporation San Antonio, United States

    As part of the Cloud Operations + Innovations (CO+I) organization, the Energy Markets team supports datacenter interconnection and energy supply contracts with utilities and third-party suppliers. Additionally, the team leads regulatory and policy strategy development with utilit ...

  • Department of the Army

    Security Specialist with Security Clearance

    2 weeks ago

    Department of the Army Fort Sam Houston, United States

    Duties * Serves as a Security Specialist in a U.S. Army Medical Command (MEDCOM) Security Office within the HQ or a Major Subordinate Command. * Serves as Security Specialist for the Information Security (INFOSEC) program. * As Foreign Disclosure Representative, coordinates speci ...

  • Hallmark University

    Accounting Clerk

    1 week ago

    Hallmark University San Antonio, United States

    About the Job · SUMMARY OF THE JOB: · Monitors both in-school and out-of-school accounts receivable, counsels' students that are past due, performs collection activities, and posts payments to accounts. · ESSENTIAL FUNCTIONS: · Cash Receipts/Posting Payments · * Enter all cash pa ...

  • QTC

    medical case specialist i-aww

    1 week ago

    QTC San Antonio, TX, United States

    Are you someone who has a knack for details and a passion for helping others? If so, we would love to speak with you · Leidos QTC Health Services is seeking a Medical Case Specialist to support our Veteran Affairs Operations in San Antonio, TX. · Who is Leidos QTC Health Services ...

  • Evestra Inc.

    Director of Regulatory Affairs

    1 week ago

    Evestra Inc. San Antonio, United States

    Our Company: · Evestra, Inc. is an emerging biopharmaceutical company that focuses on developing and commercializing womens healthcare products. Based in San Antonio, Texas, Evestras mission is to improve the health and well-being of women around the world through innovative tec ...

  • Medtronic

    dialysis training access specialist

    5 days ago

    Medtronic San Antonio, TX , USA, United States

    _*** This role will cover central US including TX, MO, WI, MN. We prefer this person live in Houston or San Antonio ***_ · **Careers that Change Lives:** · Make an impact on patients suffering from End Stage Kidney Disease (ESKD). Help improve the patient experience by educating ...