Vice President of Regulatory Affairs

3 weeks ago

Carlsbad, United States SOLVD Health Full time

Job Description Summary

The Vice President of Regulatory Affairs is responsible for overseeing the development and execution of the Company's Quality, Clinical and Regulatory strategies for our innovative products and related services across domestic and international markets. The role provides expertise and guidance in interpreting government regulations, agency guidelines, and internal policies to assure compliance with standards.

Required Education and Experience

  • Bachelor's degree (B.A/B.S.) in related field, advanced degree strongly preferred.
  • 15 plus years related experience or equivalent in medical diagnostic/device or life science industry.
  • 5 plus years' experience in a senior management role in a commercial stage company with global operations.
  • Demonstrated experience interacting with the Food and Drug Administration (FDA) required, experience with other regulatory agencies preferred.

Essential Functions

  • Oversees the Clinical, Quality and Regulatory departments and may represent the Company externally in discussions with regulatory authorities worldwide with emphasis on US and Canada.
  • Provides efficient and effective Regulatory representation across the organization and interact with the Food and Drug Administration (FDA) and other regulatory agencies.
  • Directs and implements advancement of FDA Quality System Regulations (FDA QSR) and also supports ISO 13485 program to ensure the integrity, confidentiality and availability of information.
  • Manages Corrective and Preventive Action (CAPA). Collaborates with other associates to ensure corrective and preventive activities are effective and are managed and processed in accordance with requirements.
  • Creates regulatory strategies, systems and processes to ensure that development, registration and commercialization plans meet all federal, foreign, and company requirements to enable the effective advancement of products from design concept through marketing and post market surveillance.
  • Oversees the design, implementation and conduct of innovative clinical trials.
  • Identifies and develops strong collaborative relationships with study investigators, clinical sites and external service providers.
  • Directs the assessment and improvement of key business processes to ensure compliance with current and future regulations set forth by the US FDA and equivalent international bodies.
  • Maintains accountability for all relevant timelines and deliverables.
  • Leads clinical team to secure global regulatory approvals for pipeline products.
  • Provides strategic consultation and guidance to external and internal subject matter experts with regard to go/no-go development decision criteria on significant clinical components and implications.
  • Oversees implementation of safety strategy across studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues.
  • Manages timely reporting of clinical trial issues to regulatory authorities and the generation of clinical study reports.
  • Participates in defining and developing broad strategies consistent with business objectives and clinical and regulatory requirements.
  • Ensures that New Product Development teams have appropriate clinical and regulatory representation for all key development programs.
  • Supports the development of strategic and tactical plans for all regulatory and clinical submissions including all US and OUS filings, ensures completeness, administrative and scientific accuracy; facilitates timely government approvals for marketing new and modified products.
  • Provides leadership to a team of Clinical Training Coordinators (CTCs), participating in development, performance appraisal, merit recommendation, and promotion of staff.
  • Represents company by acting as a liaison between external collaborators and internal stakeholders.
  • Leads all regulatory audit, compliance and corrective action processes.
  • Partners with Quality, R&D, Legal, Operations, and other appropriate department leaders in overseeing entire product realization efforts to ensure integrity and quality of data.
  • Provides insight into the potential regulatory risks and benefits of business plans, including directing alternative action plans based on risk/benefit analyses.
  • Participates as a member of the leadership team in defining the strategy, direction and vision of the organization.

  • Vice President, Integrated Service Delivery

    1 week ago

    Carlsbad, United States Breg, Inc. Full time

    **Are you looking for an exciting opportunity?** We currently have a full-time opening for a Vice President, Integrated Service Delivery. The Vice President, Integrated Service Delivery is a strategic and hands-on operational leader with a distinguished background in program management and logistics who has also demonstrated tangible success in developing...

  • Vice President of People

    2 weeks ago

    Carlsbad, California, United States Vuori, Inc Full time

    Job Description We’re seeking an experienced and dynamic People & Culture (Human Resources) leader to join our team as a Vice President, People & Culture - Business Partners. This role works across our HQ and retail teams, and will be instrumental in the creation and execution of our P&C strategy, aligning P&C initiatives and Talent Strategies with...

  • Administrative Support Supervisor

    2 days ago

    Carlsbad, United States Pinnacle Recovery, Inc. Full time

    **Job Title: Administrative Support Supervisor** **Location: Office-based** *** **Position Summary**: The Administrative Support Supervisor at Pinnacle Recovery, Inc. will oversee the correspondence team and administrative support functions, ensuring effective management and operational excellence. This role involves supervising a diverse team of...

  • Administrative Support Supervisor

    2 days ago

    Carlsbad, United States Pinnacle Recovery, Inc. Full time

    Job DescriptionJob DescriptionJob Title: Administrative Support SupervisorLocation: Office-basedJob Type: Full-timePosition Summary:The Administrative Support Supervisor at Pinnacle Recovery, Inc. will oversee the correspondence team and administrative support functions, ensuring effective management and operational excellence. This role involves supervising...

  • Assistant Property Manager

    6 days ago

    Carlsbad, United States Regent Properties Full time

    Assistant Property Manager Regent Properties Carlsbad, CA Job description: Regent Property Management Services is seeking a highly motivated, hard-working, Assistant Property Manager to join our growing team in Carlsbad, CA. The Assistant Property Manager will be part of a management team supporting several commercial properties, responding to tenant...

  • Assistant Property Manager

    6 days ago

    Carlsbad, United States Regent Properties Full time

    Assistant Property Manager Regent Properties – Carlsbad, CAJob description:Regent Property Management Services is seeking a highly motivated, hard-working, Assistant Property Manager to join our growing team in Carlsbad, CA. The Assistant Property Manager will be part of a management team supporting several commercial properties, responding to tenant...

  • Assistant Property Manager

    7 days ago

    Carlsbad, United States Regent Properties Full time

    Assistant Property Manager Regent Properties – Carlsbad, CAJob description:Regent Property Management Services is seeking a highly motivated, hard-working, Assistant Property Manager to join our growing team in Carlsbad, CA. The Assistant Property Manager will be part of a management team supporting several commercial properties, responding to tenant...

  • Equipment Validation Specialist

    17 hours ago

    Carlsbad, United States Portal Insulin LLC Full time

    Company Background Portal Insulin LLC (Portal) is a pre-clinical company developing an insulin formulation for use in treating diabetes mellitus. Portal’s primary mission is to provide a stable insulin product for use in implantable pumps. Objectives The successful candidate will be responsible for ensuring all equipment used in operations to run tests and...

  • Equipment Validation Specialist

    4 weeks ago

    Carlsbad, United States Portal Insulin LLC Full time

    Company Background Portal Insulin LLC (Portal) is a pre-clinical company developing an insulin formulation for use in treating diabetes mellitus.Portals primary mission is to provide a stable insulin product for use in implantable pumps. Objectives The successful candidate will be responsible for ensuring all equipment used in operations to run tests and...

  • Equipment Validation Specialist

    1 month ago

    Carlsbad, United States Portal Insulin LLC Full time

    Company BackgroundPortal Insulin LLC (Portal) is a pre-clinical company developing an insulin formulation for use in treating diabetes mellitus.  Portal’s primary mission is to provide a stable insulin product for use in implantable pumps. ObjectivesThe successful candidate will be responsible for ensuring all equipment used in operations to run tests...

  • Equipment Validation Specialist

    1 month ago

    Carlsbad, United States Portal Insulin LLC Full time

    Company BackgroundPortal Insulin LLC (Portal) is a pre-clinical company developing an insulin formulation for use in treating diabetes mellitus.  Portal’s primary mission is to provide a stable insulin product for use in implantable pumps. ObjectivesThe successful candidate will be responsible for ensuring all equipment used in operations to run tests...

  • Equipment Validation Specialist

    1 month ago

    Carlsbad, United States Portal Insulin LLC Full time

    Company BackgroundPortal Insulin LLC (Portal) is a pre-clinical company developing an insulin formulation for use in treating diabetes mellitus.  Portal’s primary mission is to provide a stable insulin product for use in implantable pumps. ObjectivesThe successful candidate will be responsible for ensuring all equipment used in operations to run tests...

  • Clinical Research Manager

    2 weeks ago

    Carlsbad, United States Atec Spine Full time

    An ATEC Clinical Research Manager (CRM) supports the company's Clinical Research initiatives by managing the clinical research operations and successful execution of clinical studies and data collection efforts in partnership with our clinical practice partners. Specifically, the position is responsible for the management of research activities spanning from...

  • Land Development Project Manager

    7 days ago

    Carlsbad, United States SoCal Residential Full time

    Job DescriptionJob DescriptionWe are seeking a highly skilled and experienced Project Manager to join our Land Development team in Carlsbad.As a Project Manager, you will be responsible for assisting the Vice President of Land Development in land acquisition and due diligence; managing various aspects of project development from acquisition through...

  • Sr. Manager, Global Brand Marketing

    3 weeks ago

    Carlsbad, United States Bowers & Wilkins Full time

    Sr. Manager, Global Brand Marketing page is loaded Sr. Manager, Global Brand Marketing Apply locations Carlsbad, CA time type Full time posted on Posted 3 Days Ago job requisition id JR100959 Position Summary / Main purpose of the role: Reporting to the Vice President of Global Marketing, the Senior Manager of Global Brand Marketing will guide all brand and...

  • Director, HR, Corporate Functions

    2 weeks ago

    Carlsbad, CA, United States ThermoFisher Full time

    Job DescriptionJob Title: Director Human ResourcesWhen you join us at Thermo Fisher Scientific, you’ll be part a thriving organization that enables our customers to make the world healthier, cleaner and safer. With our outstanding financial performance, leading market positions and the largest investment in innovation in the industry, we give our people...

  • Health Assistant

    3 weeks ago

    Carlsbad, United States Texas Department of Aging & Disability Services Full time

    Job Description: Health Assistant Come work in an environment where we truly value and respect those we serve and believe in the mission that all people can achieve a higher level of wellness and independence. The state supported living centers serve people with intellectual and developmental disabilities who are medically fragile or who have behavioral...