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Regulatory affairs specialist Jobs in Frisco, TX

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Regulatory affairs specialist • frisco tx

Last updated: 1 day ago
  • Promoted
Manager Clinical Affairs

Manager Clinical Affairs

MB&APlano, TX, US
Full-time
This role is ideal for an experienced clinical professional ready to own key components of global clinical programs, collaborate across teams, and help shape the future of clinical innovation in a ...Show moreLast updated: 21 days ago
  • Promoted
Sr Medicaid Reimbursement Regulatory Analyst

Sr Medicaid Reimbursement Regulatory Analyst

ZelisPlano, TX, US
Full-time
Zelis is modernizing the healthcare financial experience for all by providing a connected platform that bridges the gaps and aligns interests across payers, providers, and healthcare consumers.This...Show moreLast updated: 20 days ago
Manager, Regulatory Compliance - Gas

Manager, Regulatory Compliance - Gas

Liberty UtilitiesHayhurst, TX, US,
Full-time
This position may be located at any Liberty location •.This position is the owner of gas compliance maintenance plan standards and reporting, and is responsible for monitoring adherence to standards...Show moreLast updated: 30+ days ago
Regulatory Affairs Manager

Regulatory Affairs Manager

Katalyst HealthCares & Life SciencesPlano, TX
Full-time
The Senior Manager of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. The responsibilities include, yet are...Show moreLast updated: 30+ days ago
Energy Efficiency Regulatory Consultant

Energy Efficiency Regulatory Consultant

ClearesultTexas
Remote
Full-time
At CLEAResult, we lead the transition to a sustainable, equitable, and carbon-neutral energy-efficient future for our communities and our planet. We do that by creating a people-first culture built ...Show moreLast updated: 30+ days ago
Regulatory & Environmental Advisor

Regulatory & Environmental Advisor

PetroplanTexas
Permanent
Petroplan is actively recruiting for Regulatory & Environmental Advisor on behalf of an international exploration and production company. Based in Houston, TX, on a hybrid schedule, this individ...Show moreLast updated: 30+ days ago
  • Promoted
Regulatory Affairs Specialist

Regulatory Affairs Specialist

VirtualVocationsPlano, Texas, United States
Full-time
A company is looking for a Regulatory Affairs Specialist.Key Responsibilities Assist with compiling, preparing, reviewing, and submitting regulatory submissions to authorities in and outside the ...Show moreLast updated: 1 day ago
  • Promoted
SENIOR REGULATORY AFFAIRS SPECIALIST

SENIOR REGULATORY AFFAIRS SPECIALIST

Katalyst HealthCares and Life SciencesPlano, MA, United States
Full-time
The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion. This is a hybrid role (in office 3 days per week) based...Show moreLast updated: 1 day ago
Director, Regulatory Affairs – Texas / ERCOT

Director, Regulatory Affairs – Texas / ERCOT

Invenergy LLCTX, US
Full-time
Invenergy drives innovation in energy.Powered by decades of entrepreneurial experience and unparalleled execution, we solve the energy challenges facing our customers and communities.We provide pow...Show moreLast updated: 30+ days ago
  • Promoted
Attorney, Business & Legal Affairs

Attorney, Business & Legal Affairs

Exceleration MusicPlano, TX, US
Full-time
Exceleration Music is a global music venture focused on investing in and providing personalized solutions to independent labels and artists. The Company is a world-class record company for the futur...Show moreLast updated: 1 day ago
Regulatory Complaints Associate

Regulatory Complaints Associate

Hyundai Capital AmericaUSA, Texas, Plano
Full-time
Through our service brands Hyundai Motor Finance, Genesis Finance, and Kia Finance, Hyundai Capital America offers a wide range of financial products tailored to meet the needs of Hyundai, Genesis,...Show moreLast updated: 2 days ago
Regulatory Systems Manager

Regulatory Systems Manager

Comerica BankFrisco, TX
Full-time
This position manages regulatory rule review and writing, internal edit check logic and cross report requirements.Provides production support for bank regulatory reporting, including the quarterly ...Show moreLast updated: 30+ days ago
Medical Director (Medical Affairs)

Medical Director (Medical Affairs)

CVS HealthTexas, Work At Home, US
Remote
Full-time
Bring your heart to CVS Health.Every one of us at CVS Health shares a single, clear purpose : Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced...Show moreLast updated: 30+ days ago
Senior Specialist, Regulatory Affairs and Compliance

Senior Specialist, Regulatory Affairs and Compliance

Nordson CorporationUSA, Texas, Allen
Full-time
Interventional Solutions, Fluid Components, and Surgical Solutions, is seeking an experienced and highly motivated individual to join our team. We are committed to creating a diverse and inclusive w...Show moreLast updated: 30+ days ago
Corporate Affairs Account Manager, Insurance

Corporate Affairs Account Manager, Insurance

USAAPlano, TX, United States
Full-time
At USAA, our mission is to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the #1 choice for the military...Show moreLast updated: 15 days ago
Regulatory Affairs Advisor & Liaison

Regulatory Affairs Advisor & Liaison

Capital OnePlano, TX
Full-time +1
Center 1 (19052), United States of America, McLean, VirginiaRegulatory Affairs Advisor & Liaison.Capital One, a Fortune 500 company and one of the top 10 banks in the nation, offers a broad spectru...Show moreLast updated: 30+ days ago
  • Promoted
Quality and Regulatory Specialist

Quality and Regulatory Specialist

Formulife, Inc.Allen, TX, US
Full-time
The Quality and Regulatory Specialist ensures the highest standards of product quality and regulatory compliance.This role involves implementing and maintaining quality management systems, conducti...Show moreLast updated: 30+ days ago
  • Promoted
Senior Regulatory Reporting Specialist

Senior Regulatory Reporting Specialist

ComericaFrisco, TX, US
Full-time
Senior Regulatory Reporting Specialist.Assist in the preparation and review of reports for bank regulatory agencies, including the quarterly Call and FR Y reports, regulatory capital calculations a...Show moreLast updated: 21 days ago
Regulatory / TPM

Regulatory / TPM

Genesis10Plano, TX
Temporary
Genesis10 is currently seeking an IT Project Manager with our client in the financial industry located in Charlotte, NC, Plano, TX, and Pennington, NJ. This is a 12+ month contract position.Responsi...Show moreLast updated: 30+ days ago
  • Promoted
Sr Medicaid Reimbursement Regulatory Analyst

Sr Medicaid Reimbursement Regulatory Analyst

Zelis Healthcare, LLCPlano, TX, United States
Full-time
Zelis is modernizing the healthcare financial experience for all by providing a connected platform that bridges the gaps and aligns interests across payers, providers, and healthcare consumers.This...Show moreLast updated: 24 days ago
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Manager Clinical Affairs

Manager Clinical Affairs

MB&APlano, TX, US
21 days ago
Job type
  • Full-time
Job description

About the Role

We are seeking a Clinical Affairs Manager who combines operational precision with strategic awareness. This role is ideal for an experienced clinical professional ready to own key components of global clinical programs, collaborate across teams, and help shape the future of clinical innovation in a high-growth medical device environment. You will support and execute on strategies that deliver regulatory success, evidence generation, and improved patient outcomes.

Key Responsibilities

Strategic & Tactical Execution

  • Support the development and execution of global clinical strategies aligned with company objectives.
  • Partner with executive leadership to deliver clinical data that informs product development, market access, and regulatory pathways.
  • Assist in integrating digital health technologies, AI, or robotics into clinical trials and post-market evidence strategies.

Clinical Study Operations

  • Manage the design, implementation, and oversight of clinical trials (pre- and post-market), ensuring adherence to regulatory and ethical standards.
  • Drive study start-up, site selection, patient recruitment, vendor management, and trial monitoring.
  • Collaborate with CROs and study sites to ensure timely execution and high-quality data capture.
  • Regulatory & Compliance

  • Ensure clinical programs are inspection-ready and aligned with FDA, EU MDR, and international requirements.
  • Support the preparation of regulatory submissions and clinical evaluation reports (CERs).
  • Act as a liaison with regulatory, quality, and R&D teams to ensure integrated clinical strategies.
  • Team Collaboration & Communication

  • Provide day-to-day leadership to Clinical Affairs Associates or support team members, fostering a culture of accountability and innovation.
  • Prepare presentations and reports for internal stakeholders and external partners.
  • Maintain ongoing communication with key opinion leaders (KOLs), investigators, and external collaborators.
  • Qualifications

    Must-Haves :

  • 8+ years of experience in clinical research, with at least 2 years in a management or team leadership role.
  • Bachelor's degree in Life Sciences, Biomedical Engineering, or related field (Master's or advanced degree preferred).
  • Proven experience managing clinical studies in medical devices (orthopedics experience is a plus).
  • Strong working knowledge of GCP, ISO 14155, FDA, and EU MDR requirements.
  • Excellent cross-functional communication and project management skills.
  • Preferred :

  • Certification such as CCRA, CCRC, or RAC.
  • Experience with emerging tech (AI, robotics, digital health) in clinical studies.
  • Exposure to regulatory submissions and audit readiness.
  • Why Join Us

  • Play a pivotal role in advancing clinical programs for cutting-edge technologies.
  • Be part of a mission-driven company focused on innovation, purpose, and impact.
  • Enjoy competitive compensation, stock options, and flexible work arrangements.
  • Gain exposure to strategic decision-making in collaboration with senior leadership.