Current jobs related to Lead Regulatory Affairs Expert - Redwood City, California - Pulmonx Corporation

  • Regulatory Affairs Director

    2 weeks ago

    Redwood City, California, United States Biomea Fusion, Inc. Full time

    Job Title: Associate Director, Regulatory AffairsBiomea Fusion, Inc. is seeking an experienced Associate Director, Regulatory Affairs to support the company's regulatory affairs strategies for IND/CTA/BLA/NDA filings and approvals.Key Responsibilities:Lead interactions and act as Subject Matter Expert on regulatory pharmaceutical and/or biotechnology...

  • Regulatory Affairs Director

    2 weeks ago

    Redwood City, California, United States Work In Biotech Full time

    Transformative Therapies for Autoimmune DiseasesNuvig Therapeutics is pioneering novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are designed to be active for a wide range of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with existing therapies.Director, Regulatory...

  • Regulatory Affairs Director

    2 weeks ago

    Redwood City, California, United States Work In Biotech Full time

    Transformative Opportunity in Regulatory AffairsNuvig Therapeutics is seeking a highly experienced Director, Regulatory Affairs to join our dynamic team. As a key member of our regulatory affairs department, you will be responsible for developing and implementing global regulatory strategies to support our investigational studies. This is an exciting...

  • Director of Regulatory Affairs

    2 weeks ago

    Redwood City, California, United States Nuvig Therapeutics Inc. Full time

    Transformative Therapies for Autoimmune DiseasesNuvig Therapeutics is pioneering novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are designed to be active for a wide range of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with existing therapies.Director, Regulatory...

  • Regulatory Affairs Director

    4 weeks ago

    Redwood City, California, United States Work In Biotech Full time

    Transformative Therapies for Autoimmune DiseasesNuvig Therapeutics is pioneering novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are designed to be active for a wide range of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with existing therapies.Director, Regulatory...

  • Regulatory Affairs Director

    2 weeks ago

    Redwood City, California, United States Revolution Medicines Full time

    Revolution Medicines: A Leader in Precision OncologyWe are seeking an experienced Associate Director of Regulatory Affairs to join our team at Revolution Medicines, a clinical-stage precision oncology company dedicated to developing novel targeted therapies for RAS-addicted cancers.The OpportunityAs a key member of our Regulatory Affairs team, you will...

  • Regulatory Affairs Manager

    3 weeks ago

    Redwood City, California, United States Corcept Therapeutics Full time

    Job SummaryCorcept Therapeutics is seeking a highly skilled Regulatory Affairs professional to join our team in Menlo Park, CA. As a Sr. Manager, Corporate Regulatory Affairs, you will play a critical role in partnering with Regulatory Affairs leaders to obtain and maintain regulatory filings and registrations for domestic and international regions.Key...

  • Regulatory Affairs Senior Manager

    1 week ago

    Redwood City, California, United States REVOLUTION Medicines Full time

    At Revolution Medicines, we are committed to developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.The Senior Manager of Regulatory Affairs will play a crucial role in providing project teams with regulatory advice, managing and coordinating various Regulatory Affairs activities within and between departments, and obtaining...

  • Regulatory Affairs Director

    1 month ago

    Redwood City, California, United States Work In Biotech Full time

    Transformative Therapies for Autoimmune DiseasesNuvig Therapeutics is pioneering novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are designed to be active for a wide range of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with existing therapies.Director, Regulatory...

  • Regulatory Affairs Manager

    4 weeks ago

    Redwood City, California, United States Corcept Therapeutics Full time

    Regulatory Affairs ManagerCorcept Therapeutics is a leader in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). Our team has discovered over 1,000 selective proprietary cortisol modulators, and we continue to unlock the possibilities of cortisol modulation as a way to treat...

  • Senior Director Regulatory Affairs

    2 weeks ago

    Redwood City, California, United States Corcept Therapeutics Full time

    Job Title: Senior Director Regulatory AffairsCorcept Therapeutics is a leading biopharmaceutical company dedicated to the research and development of cortisol modulators. We are seeking a highly experienced Senior Director Regulatory Affairs to join our team and support the commercialization of our late-stage programs.Key Responsibilities:Develop and...

  • Senior Director Regulatory Affairs

    2 weeks ago

    Redwood City, California, United States Corcept Therapeutics Full time

    Job Title: Senior Director Regulatory AffairsCorcept Therapeutics is a leading biopharmaceutical company dedicated to the research and development of cortisol modulators. We are seeking a highly experienced Senior Director Regulatory Affairs to support the commercialization of our late-stage programs.Key Responsibilities:Develop and implement regulatory...

  • Senior Manager of Regulatory Affairs

    2 weeks ago

    Redwood City, California, United States REVOLUTION Medicines Full time

    Revolution MedicinesRevolution Medicines is a clinical-stage precision oncology company dedicated to developing innovative targeted therapies for RAS-addicted cancers. Our research pipeline focuses on RAS(ON) Inhibitors and RAS Companion Inhibitors, designed to suppress diverse oncogenic variants of RAS proteins.The OpportunityWe are seeking a highly skilled...

  • Regulatory Affairs Manager

    1 month ago

    Redwood City, California, United States Corcept Therapeutics Full time

    Job SummaryCorcept Therapeutics is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing the company's regulatory interface with domestic and international health authorities.Key ResponsibilitiesManage the development and deployment of the regulatory...

  • Regulatory Affairs Manager

    2 weeks ago

    Redwood City, California, United States Revolution Medicines Full time

    Revolution Medicines: A Leader in Precision OncologyWe are seeking a highly skilled Senior Manager of Regulatory Affairs to join our team at Revolution Medicines, a clinical-stage precision oncology company dedicated to developing novel targeted therapies for RAS-addicted cancers.The OpportunityAs a key member of our Regulatory Affairs team, you will provide...

  • Regulatory Affairs Director

    1 week ago

    Redwood City, California, United States Retro Full time

    Regulatory Affairs DirectorRetro is seeking a highly skilled Regulatory Affairs Director to lead our regulatory efforts and help get our therapeutics from pre-IND to first-in-human clinical trial. As a key member of our team, you will oversee and advance the lifecycle of all of Retro's therapeutics, acting as the bridge between our internal research and...

  • Regulatory Affairs Specialist

    4 weeks ago

    Redwood City, California, United States REVOLUTION Medicines Full time

    Revolution Medicines: A Leader in Precision OncologyRevolution Medicines is a clinical-stage precision oncology company dedicated to developing innovative targeted therapies for RAS-addicted cancers. Our R&D pipeline focuses on RAS(ON) Inhibitors and RAS Companion Inhibitors, designed to suppress diverse oncogenic variants of RAS proteins and enhance...

  • Regulatory Affairs Director

    1 month ago

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

    About the ClientOur client is a pioneering company in the field of robotic systems for medical diagnosis and treatment, with a focus on advanced surgical interventions for complex conditions.Job SummaryWe are seeking a highly qualified Director of Regulatory Affairs to join our dynamic R&D team. This role is critical in driving the development of innovative...

  • Regulatory Affairs Manager

    7 days ago

    Redwood City, California, United States Corcept Therapeutics Full time

    At Corcept Therapeutics, we are dedicated to advancing the possibilities of cortisol modulation as a way to treat serious diseases.This role is responsible for partnering with Regulatory Affairs leaders to obtain and maintain regulatory filings and registrations for domestic and international regions.The Sr. Manager will coordinate activities with internal...

  • Regulatory Affairs Senior Associate

    7 days ago

    Redwood City, California, United States REVOLUTION Medicines Full time

    At Revolution Medicines, we are committed to developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. As a Senior Associate, Regulatory Affairs, you will play a crucial role in supporting our team in day-to-day operational aspects of the department and interacting with global regulatory authorities.The Opportunity: This...

Lead Regulatory Affairs Expert

2 months ago

Redwood City, California, United States Pulmonx Corporation Full time

Company Overview

Pulmonx 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 provides a non-surgical option for lung volume reduction, significantly enhancing patient care.

Position Summary

The Senior Regulatory Affairs Specialist will play a pivotal role in supporting essential regulatory functions within the organization. This position is responsible for ensuring that all marketing materials related to medical devices adhere to FDA regulations, international standards, and internal policies. The individual will be instrumental in maintaining regulatory compliance through careful evaluation of marketing communications, labeling, and promotional strategies.

Key Responsibilities:

  • Material Review: Execute comprehensive assessments of promotional and advertising content, including digital and print formats, to guarantee alignment with FDA regulations and industry norms.
  • Regulatory Submissions: Prepare and manage regulatory submissions for product approvals in both international and domestic markets, ensuring timely processing.
  • Strategic Compliance: Formulate and implement regulatory strategies for promotional materials, optimizing product visibility while ensuring adherence to regulations.
  • Monitoring Compliance: Stay informed on international regulatory requirements and updates, adjusting strategies as necessary to maintain compliance.
  • Collaborative Efforts: Partner with marketing, legal, and clinical teams to ensure promotional strategies are consistent with regulatory mandates and business goals.
  • Design Input: Provide regulatory insights during product design and development phases, ensuring that compliance considerations are integrated from the beginning.
  • Post-Market Oversight: Supervise post-market surveillance activities to uphold compliance and safety of marketed products, including incident reporting and recalls.
  • Adverse Event Management: Oversee the tracking and reporting of adverse events and product complaints to relevant regulatory bodies.
  • Audit Support: Prepare for and assist with compliance audits and inspections related to post-market activities.
  • Training and Development: Offer regulatory training and guidance to internal teams regarding international regulatory standards and updates.
  • Stakeholder Relations: Engage with international regulatory authorities to facilitate processes and address inquiries, fostering positive relationships.
  • Communication: Provide regular updates to management and compile data specific to International Regulatory Affairs.
  • Project Management: Effectively manage the execution of both short- and long-term objectives, ensuring accountability for results.
  • Interpersonal Skills: Demonstrate strong interpersonal abilities, fostering a collaborative work environment.
  • Self-Motivation: Exhibit a proactive approach, inspiring and motivating colleagues.
  • Goal Orientation: Maintain a focus on targets with a positive and solution-oriented mindset.
  • Additional Duties: Perform other responsibilities as assigned.

Qualifications:

  • Bachelor's degree in Life Sciences, Regulatory Affairs, or a related discipline; Master's degree preferred. RAPS-RAC certification is a plus.
  • 5-8 years of experience in regulatory affairs, particularly with Class II or Class III medical devices, emphasizing Advertising and Promotion and Standards review.
  • Proven track record in regulatory submissions and registrations across various markets.
  • In-depth knowledge of FDA and international regulatory standards, including ISO 13485 and risk management processes for medical devices.
  • Demonstrated ability in project management.
  • Exceptional organizational skills, capable of managing multiple projects and deadlines efficiently.
  • Strong communication and interpersonal skills, with the ability to collaborate across diverse cultures and regions.
  • Ability to thrive in a fast-paced and dynamic work environment.
  • Excellent presentation and communication skills, both written and verbal.
  • Proficient in creating clear and concise technical documentation.

Additional Expectations:

  • Adherence to all company policies and procedures is mandatory.
  • Ensure compliance with all legal and regulatory requirements applicable to the company's product lines and markets.

Pulmonx Corporation is committed to diversity and equal opportunity in employment. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.