Regulatory Affairs Manager, International

1 week ago

Redwood City, California, United States Pulmonx Full time

Company Overview

Pulmonx is a leading innovator in Interventional Pulmonology, Planning Tools, and Treatments for Obstructive Lung Disease. Based in the United States and Switzerland, Pulmonx is the manufacturer of the Zephyr Valve. The Zephyr Valve was granted breakthrough status and approved by the FDA in 2018, as it represents a breakthrough technology offering bronchoscopic lung volume reduction without surgery and its associated risks. This device offers a significant, clinically meaningful advantage over the current standard of care and therefore, its availability is also in the best interest of patients.

Position Overview

The Manager of International Regulatory Affairs will be responsible for overseeing all regulatory aspects of devices marketed and sold in international markets, with a specific focus on OUS, Japan, China, and Korea. This position is responsible for ensuring that all products meet all regulatory requirements, assisting with international regulatory strategy, working cross-functionally, and maintaining compliance with international standards.

Key Responsibilities

  • Regulatory Strategy Development: Develop and implement regulatory strategies for product registration and market entry in Japan, China, Korea, and other international markets as required.
  • Submission and Approvals: Prepare and submit regulatory dossiers for product registration in international markets. Manage all aspects of the submission process to ensure timely approval of products.
  • Regulatory Compliance: Monitor and ensure compliance with all international regulatory requirements and changes. Adapt strategies and processes as needed to maintain compliance.
  • Cross-functional Collaboration: Work closely with R&D, Quality Assurance, and Clinical Affairs departments to gather necessary documentation and ensure regulatory strategies align with overall business objectives.
  • Regulatory Input in Design: Provide expert regulatory advice during the product design and development phases, ensuring regulatory considerations are integrated into product planning from the outset.
  • Data Oversight: Oversee the collection, analysis, and interpretation of clinical data to ensure it meets regulatory standards for submissions, in partnership with the Medical Affairs and Clinical teams.
  • Clinical Study Compliance: Ensure clinical studies are designed and executed in compliance with regulatory requirements, and that study results are reported accurately and transparently, in partnership with the Medical Affairs and Clinical teams.
  • Market Surveillance: Oversee post-market surveillance activities to ensure ongoing compliance and safety of marketed devices. Handle incident reporting and recalls in coordination with local authorities.
  • Regulatory Maintenance: Manage essential post-market activities such as product registrations, renewals, and modifications. Ensure compliance with post-market surveillance requirements.
  • Adverse Event Reporting: Oversee the monitoring and reporting of adverse events and product complaints to regulatory authorities in the applicable international regions.
  • Audit Preparation: Prepare and support post-market compliance audits and inspections.
  • Training and Guidance: Provide regulatory guidance and training to internal teams and stakeholders on international regulatory requirements and changes.
  • Stakeholder Engagement: Liaise with international regulatory authorities and bodies to facilitate processes and address queries. Build and maintain positive relationships with regulatory representatives.
  • SOP Creation: Lead the development of Standard Operating Procedures (SOPs) that establish clear, compliant processes for all aspects of regulatory affairs. Ensure that SOPs are in line with the latest regulatory guidelines and corporate policies.
  • Continuous Improvement: Regularly review and assess existing SOPs to identify opportunities for process improvements and efficiency gains. Implement updates to SOPs to reflect changes in regulatory requirements, technological advancements, or operational best practices.
  • Quality Assurance: Collaborate with the Quality Assurance (QA) department to ensure that SOPs meet both regulatory and quality standards. Facilitate training sessions for relevant teams to ensure thorough understanding and correct implementation of revised or new SOPs.
  • Cross-functional Alignment: Ensure that SOPs align with procedures from other departments that interact with regulatory processes, such as clinical affairs, product development, and manufacturing, to maintain consistency and compliance across the organization.
  • Provide regular updates to the management team and lead and collate data specific to Domestic Regulatory Affairs for the organization.
  • Communication: Provide regular updates to the management team and lead and collate data specific to International Regulatory Affairs for the organization.
  • Manages the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results.
  • Excellent interpersonal skills
  • A self-starter, motivated, and able to positively motivate others.
  • Focused, target-driven, with a positive, can-do attitude.
  • Other duties as assigned.

  • International Regulatory Affairs Manager

    2 weeks ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Manager, Regulatory Affairs, InternationalPulmonx is a leading entity in the field of Interventional Pulmonology, specializing in innovative tools and therapies for Obstructive Lung Disease. Our commitment to excellence is exemplified by our flagship product, the Zephyr Valve, which has been recognized for its groundbreaking technology in the realm of...

  • International Regulatory Affairs Manager

    1 week ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Manager, Regulatory Affairs, InternationalPulmonx is a leading innovator in the field of Interventional Pulmonology, specializing in advanced tools and therapies for Obstructive Lung Disease. The company is recognized for its groundbreaking Zephyr Valve, which received breakthrough designation from the FDA due to its significant clinical advantages in lung...

  • International Regulatory Affairs Manager

    2 weeks ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Manager, Regulatory Affairs, InternationalPulmonx is a recognized leader in the field of Interventional Pulmonology, specializing in innovative tools and therapies for obstructive lung diseases. Our flagship product, the Zephyr Valve, has received significant accolades, including breakthrough designation from the FDA due to its unique approach to lung volume...

  • International Regulatory Affairs Manager

    2 weeks ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Manager, Regulatory Affairs, InternationalPulmonx is a recognized leader in the field of Interventional Pulmonology, specializing in innovative planning tools and treatments for obstructive lung diseases. With operations in multiple global locations, Pulmonx is renowned for its Zephyr Valve, a device that received breakthrough designation from the FDA in...

  • International Regulatory Affairs Manager

    1 week ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Manager, Regulatory Affairs, InternationalPulmonx is a leading organization in the field of Interventional Pulmonology, offering innovative solutions and therapies for Obstructive Lung Disease. The company is recognized for its development of the Zephyr Valve, a groundbreaking device that received breakthrough designation from the FDA in June 2018, as it...

  • International Regulatory Affairs Manager

    2 weeks ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Manager, Regulatory Affairs, InternationalPulmonx is a leading entity in the field of Interventional Pulmonology, specializing in innovative solutions and therapies for Obstructive Lung Disease. The company is recognized for its development of the Zephyr Valve, a device that has achieved breakthrough status and received FDA approval due to its significant...

  • Regulatory Affairs Director

    1 day ago

    Redwood City, California, United States HealthCare Recruiters International Full time

    **About the Role**HealthCare Recruiters International is seeking a highly qualified Director of Regulatory Affairs to join our team. As a key member of our R&D team, you will play a critical role in the development and commercialization of innovative robotic systems for the diagnosis and treatment of patients with advanced surgical interventions.**Key...

  • Regulatory Affairs Director

    1 week ago

    Redwood City, California, United States Pulmonx Full time

    About PulmonxPulmonx is a leading medical device company dedicated to developing innovative solutions for respiratory health. We are seeking an experienced Regulatory Affairs Director to join our dynamic team.Key ResponsibilitiesRegulatory Strategy Development: Develop and implement comprehensive regulatory strategies that align with company goals and ensure...

  • Regulatory Affairs Director

    1 day ago

    Redwood City, California, United States Adverum Biotechnologies Full time

    About the RoleWe are seeking a highly experienced and skilled Regulatory Affairs Director to lead our CMC Regulatory strategy for Adverum's gene therapy program/s. As a key member of our team, you will be responsible for developing, executing, and advising on global Regulatory CMC strategies through all phases of our development program/s.Key...

  • Regulatory Affairs Director

    8 hours ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Job SummaryWe are seeking a highly experienced Regulatory Affairs Director to join our team at Pulmonx Corporation. As a key member of our leadership team, you will be responsible for implementing regulatory strategies worldwide to ensure compliance with regulatory requirements and obtain regulatory approval for our products.Key ResponsibilitiesRegulatory...

  • Lead Regulatory Affairs Expert

    1 week ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Company OverviewPulmonx is a global leader in the field of interventional pulmonology, providing innovative planning tools and treatments for obstructive lung disease. With operations in multiple locations, Pulmonx is renowned for its development of the Zephyr Valve, a groundbreaking device that has received FDA breakthrough designation due to its...

  • Lead Regulatory Affairs Expert

    1 week ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Company OverviewPulmonx is a prominent entity in the field of Interventional Pulmonology, specializing in innovative tools and therapies for Obstructive Lung Disease. With locations in California and Switzerland, Pulmonx is recognized for its groundbreaking Zephyr Valve, which received FDA breakthrough designation in June 2018 due to its significant...

  • Lead Regulatory Affairs Expert

    2 weeks ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Company OverviewPulmonx is a pioneering organization in the field of Interventional Pulmonology, offering innovative solutions and therapies for Obstructive Lung Disease. With operations in multiple locations, Pulmonx is renowned for developing the Zephyr Valve, a device that has achieved breakthrough designation from the FDA, recognized for its significant...

  • Lead Regulatory Affairs Specialist

    1 week ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Company OverviewPulmonx is a global frontrunner in the field of Interventional Pulmonology, offering innovative tools and treatments for obstructive lung diseases. With headquarters in Redwood City, California, and Neuchâtel, Switzerland, Pulmonx is renowned for its development of the Zephyr Valve, a device that has received breakthrough designation and FDA...

  • Lead Regulatory Affairs Expert

    1 week ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Company OverviewPulmonx is a leading organization in the field of Interventional Pulmonology, offering innovative solutions and therapies for Obstructive Lung Disease. With operations in multiple locations, Pulmonx is renowned for developing the Zephyr Valve, a groundbreaking device that received FDA breakthrough designation in June 2018. This technology...

  • Lead Regulatory Affairs Specialist

    2 weeks ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Company OverviewPulmonx is a global leader in interventional pulmonology, specializing in innovative tools and treatments for obstructive lung disease. With operations in multiple countries, Pulmonx is renowned for developing the Zephyr Valve, a device that has received breakthrough designation from the FDA due to its significant advantages in non-surgical...

  • Lead Regulatory Affairs Expert

    2 weeks ago

    Redwood City, California, United States Pulmonx Full time

    Company OverviewAre you equipped with the necessary qualifications and expertise for this role? Discover more below.Pulmonx stands as a Global Leader in Interventional Pulmonology, offering innovative Planning Tools and Treatments for Obstructive Lung Disease. The company is recognized for its development of the Zephyr Valve, a groundbreaking device.The...

  • Lead Regulatory Affairs Expert

    2 weeks ago

    Redwood City, California, United States Pulmonx Full time

    Company OverviewAre you equipped with the necessary qualifications and expertise for this role? Read on to find out more.Pulmonx stands as a global frontrunner in the field of Interventional Pulmonology, offering innovative planning tools and therapies for obstructive lung disease. The company is renowned for its development of the Zephyr Valve, a...

  • Senior Manager, Regulatory Compliance and Affairs

    2 weeks ago

    Redwood City, California, United States Corcept Therapeutics Full time

    Corcept Therapeutics is at the forefront of innovative research and development focused on cortisol modulators, specialized molecules that influence cortisol activity at the glucocorticoid receptor (GR). With a proven history of over 1,000 proprietary cortisol modulators, we are dedicated to advancing this critical area of medicine.Since receiving FDA...

  • Regulatory Affairs and Quality Assurance Director

    1 week ago

    Redwood City, California, United States Pulmonx Full time

    Job SummaryThe Vice President, Regulatory Affairs and Quality Assurance will lead the development and implementation of regulatory strategies worldwide to ensure compliance with quality regulations and standards. This role will oversee the preparation of regulatory submissions, manage global licensing and product registration, and interact with regulatory...