Talent.com
VP, Regulatory & Quality

VP, Regulatory & Quality

Noah MedicalSan Carlos, CA, US
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

VP, Regulatory & Quality

Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.

About The Team

The Vice President of Regulatory and Quality plays a crucial role in ensuring compliance with regulatory standards and maintaining the highest levels of quality within the organization. This executive-level position requires a deep understanding of regulatory requirements, quality management systems, and a strategic mindset to drive continuous improvement initiatives. The Vice President of Regulatory and Quality oversees all aspects of regulatory affairs, quality management systems, and quality assurance to uphold product integrity and meet regulatory obligations.

A Day In The Life Of Our VP, Regulatory and Quality at Noah Medical

Regulatory Compliance :

  • Stay abreast of relevant regulatory requirements, guidelines, and industry best practices.
  • Develop and implement strategies to ensure compliance with local, national, and international regulations.
  • Advocate for the company's regulatory and quality interests and represent the organization in regulatory discussions, audits, inspections, and quality management reviews.
  • Ensure regulatory compliance by overseeing advertisement and promotional programs, including review and approval of marketing materials, advertising campaigns, and promotional activities in alignment with FDA regulations and international standards.

Quality Management Systems :

  • Establish and maintain robust quality management systems (QMS) to support the organization's operations.
  • Lead the development, implementation, and maintenance of quality policies, procedures, and processes.
  • Monitor and evaluate the effectiveness of the QMS through audits, inspections, and metrics analysis.
  • Quality Assurance :

  • Lead Design Control program to ensure that design inputs, verification, validation, and design transfer activities meet regulatory requirements and quality standards.
  • Develop and implement post-market surveillance strategies, including complaint handling, adverse event reporting, and corrective and preventive action (CAPA) processes, to ensure ongoing product safety and regulatory compliance.
  • Collaborate with cross-functional teams to address quality issues and drive corrective and preventive actions.
  • Risk Management :

  • Identify and assess regulatory and quality risks associated with products, processes, and systems.
  • Develop and implement risk management strategies for hardware and software components, including risk assessment, mitigation plans, and risk-based decision-making processes to minimize compliance and quality-related risks.
  • Provide guidance on risk management principles and practices to relevant stakeholders.
  • Leadership and Team Management :

  • Recruit, develop, and retain a high-performing team of regulatory and quality professionals.
  • Foster a culture of accountability, collaboration, and continuous improvement within the department.
  • Provide leadership, guidance, and mentorship to team members to support their professional growth and development.
  • Provide strategic regulatory / quality guidance to the leadership team in support of decision-making.
  • Provide strategic leadership in regulatory affairs and quality assurance, develop regulatory and quality strategies aligned with business objectives, and oversee the execution of regulatory and quality plans throughout the product lifecycle.
  • Cross-Functional Collaboration :

  • Collaborate with other functional areas, including R&D, manufacturing, supply chain, and commercial teams, to integrate regulatory and quality considerations into product development and commercialization strategies.
  • Serve as a subject matter expert on regulatory and quality matters, providing guidance and support to cross-functional teams.
  • Continuous Improvement :

  • Drive continuous improvement initiatives to enhance regulatory compliance and quality performance.
  • Champion quality excellence and promote a culture of quality throughout the organization.
  • Implement quality improvement tools and methodologies to streamline processes and optimize resource utilization.
  • About You

  • Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred.
  • Extensive experience in regulatory affairs and quality management within the medical device, biotechnology, or related industries.
  • Proven track record of successful regulatory submissions, quality audits, and continuous improvement initiatives including clearance of multiple complex medical devices, i.e. devices that include capital hardware, disposable hardware, and software.
  • In-depth knowledge of regulatory requirements, standards, and guidelines (e.g., FDA, CFDA, EU MDR, EMA, ISO).
  • Strong understanding of quality management systems, including GMP, GCP, and ISO standards, e.g. 13485.
  • Excellent leadership, communication, and interpersonal skills.
  • Strategic mindset with the ability to drive change and foster innovation.
  • Thrives in a fast-paced, hands-on environment that is frequently changing.
  • Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to diverse audiences
  • Exceptional problem-solving and decision-making abilities.
  • Demonstrated experience in building, leading, and developing high-functional teams, with demonstrated success in fostering collaboration, innovation, and professional growth.
  • California Pay Range $240,000 - $295,000 USD

    Benefits & Perks (For Full Time Employees) :

  • Competitive Salary
  • Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
  • Equity & Bonus Program
  • Life Insurance (company paid & supplemental) and Disability insurance
  • Mental health support through medical insurance programs
  • Legal and Pet Insurance
  • 12+ paid holidays, 15-20 days of PTO + sick time
  • Paid parental leave
  • In-office snacks and beverages
  • In-office lunch stipend
  • Learning & Development Opportunities : On-demand online training and book reimbursement
  • Team building and company organized social and celebration events
  • Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and / or role where applicable.

    Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.

    serp_jobs.job_alerts.create_a_job

    Quality Regulatory • San Carlos, CA, US

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    VP / Head of Regulatory Affairs

    VP / Head of Regulatory Affairs

    EPM ScientificSan Mateo County, CA, United States
    serp_jobs.job_card.full_time
    A privately held, clinical-stage biotechnology company is seeking a Vice President / Head of Regulatory Affairs to join its leadership team. This role will be pivotal in shaping and executing global...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    VP, Product Development Regulatory Innovation & Sustainment

    VP, Product Development Regulatory Innovation & Sustainment

    GenentechSan Francisco, CA, United States
    serp_jobs.job_card.full_time
    This is a unique executive leadership opportunity for a visionary pioneer who sees regulation not as a hurdle, but as a dynamic ecosystem ripe for strategic and technological advancement.You will b...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Director, Quality Assurance and Regulatory Affairs

    Director, Quality Assurance and Regulatory Affairs

    Noah MedicalSan Jose, CA, US
    serp_jobs.job_card.full_time
    Director, Quality Assurance and Regulatory Affairs.Noah Medical is building the future of medical robotics.Our next generation robotic platform targets early diagnosis and treatment of patients acr...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Regulatory Affairs CMC Director

    Regulatory Affairs CMC Director

    ExelixisAlameda, CA, United States
    serp_jobs.job_card.full_time
    Provide Regulatory Affairs CMC expertise and leadership for global commercial and development projects.Develop strategic approaches to enable succesful Health Authority submissions and communicatio...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Regulatory Affairs Associate Director, IVD #4360

    Regulatory Affairs Associate Director, IVD #4360

    GRAILMenlo Park, CA, United States
    serp_jobs.job_card.full_time
    Our mission is to detect cancer early, when it can be cured.We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective tech...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Director, Global Regulatory AffairsNewFoster City

    Senior Director, Global Regulatory AffairsNewFoster City

    Mirum PharmaceuticalsSan Mateo, CA, US
    serp_jobs.job_card.full_time
    Senior Director, Global Regulatory Affairs.Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Director, CMC Regulatory

    Senior Director, CMC Regulatory

    Revolution MedicinesRedwood City, CA, US
    serp_jobs.job_card.full_time
    Global Cmc Regulatory Strategy Leader.Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Sr Director, Regulatory Affairs CMC

    Sr Director, Regulatory Affairs CMC

    GileadSan Mateo, CA, US
    serp_jobs.job_card.full_time
    At Gilead, we're creating a healthier world for all people.For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapie...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Vice President, Regulatory Affairs

    Vice President, Regulatory Affairs

    Annexon BiosciencesSan Francisco, CA, US
    serp_jobs.job_card.full_time
    Vice President, Regulatory Affairs.At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Regulatory Affairs Manager

    Regulatory Affairs Manager

    Pacer GroupSan Mateo, CA, US
    serp_jobs.job_card.full_time
    Job Title : PRC Submission Management Lead.Location : Foster City, CA 94404 (Hybrid).Seeking a seasoned PRC Submission Management Lead to support the CPC team. This specialized role requires deep expe...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Director, RA Global Regulatory Strategy

    Director, RA Global Regulatory Strategy

    AllerganSan Francisco, CA, United States
    serp_jobs.job_card.full_time
    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable i...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Associate Director or Director of Regulatory Affairs and Quality Assurance6425 Christie Avenue, Emeryville, CA

    Associate Director or Director of Regulatory Affairs and Quality Assurance6425 Christie Avenue, Emeryville, CA

    DermBiontEmeryville, CA, US
    serp_jobs.job_card.full_time
    Associate Director Or Director Of Regulatory Affairs And Quality Assurance.DermBiont is a clinical stage biotech company with multiple active INDs enabling multiple Phase 2 clinical trials.Assuming...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Director, Regulatory Affairs

    Director, Regulatory Affairs

    GileadSan Mateo, CA, US
    serp_jobs.job_card.full_time
    Director, Virology Global Regulatory Affairs.At Gilead, we're creating a healthier world for all people.For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and can...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Vice President, Regulatory Strategy

    Vice President, Regulatory Strategy

    Advanced ClinicalRedwood City, CA, United States
    serp_jobs.job_card.full_time
    Vice President, Regulatory Strategy.The Vice President, Regulatory Strategy will lead and expand a high-performing team responsible for delivering clinically focused global regulatory strategies ac...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Vice President, Head of Quality

    Vice President, Head of Quality

    Soleno Therapeutics, Inc.Redwood City, CA, United States
    serp_jobs.job_card.full_time
    Soleno is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases based in Redwood City, CA. At Soleno, we are driven by...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Vice President, Regulatory Science

    Vice President, Regulatory Science

    Revolution MedicinesRedwood City, CA, US
    serp_jobs.job_card.full_time
    Vice President Of Regulatory Science.Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted c...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Director, Regulatory Operations

    Director, Regulatory Operations

    Revolution MedicinesRedwood City, CA, United States
    serp_jobs.job_card.full_time
    The Director of Regulatory Information Management (RIM) will partner closely with the Senior Director and Head of Regulatory Operations and Planning to build, lead, and scale Revolution Medicines’ ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_hour
    • serp_jobs.job_card.promoted
    Senior Regulatory Reporting Analyst, Vice President

    Senior Regulatory Reporting Analyst, Vice President

    Direct Staffing IncSan Francisco, CA, United States
    serp_jobs.job_card.full_time
    Senior Regulatory Reporting Analyst, Vice President.Senior Regulatory Reporting Analyst, Vice President.The Senior Regulatory Reporting Analyst reports to the Regulatory Reporting Manager and is re...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30