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Lead Regulatory Affairs Specialist

2 months ago

Redwood City, California, United States Pulmonx Corporation Full time

Company Overview

Pulmonx 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 lung volume reduction.

Position Summary

The Senior Regulatory Affairs Specialist will play a pivotal role in supporting essential regulatory functions within the organization. This position is crucial for ensuring that all marketing materials associated with medical devices adhere to FDA regulations, international standards, and internal policies. The specialist will meticulously evaluate marketing communications, labeling, and promotional practices to uphold regulatory compliance.

Key Responsibilities:

  • Material Review: Execute comprehensive evaluations of promotional and advertising content, including digital and print formats, to confirm adherence to FDA regulations and industry norms.
  • Regulatory Submissions: Prepare and manage regulatory submissions for product approvals in both international and domestic markets, ensuring a streamlined approval process.
  • Strategic Compliance: Formulate and implement regulatory strategies for promotional materials, enhancing product visibility while maintaining compliance.
  • Ongoing Compliance Monitoring: Stay informed on international regulatory requirements and modifications, adjusting strategies as necessary to ensure continued compliance.
  • Collaborative Efforts: Partner with marketing, legal, and clinical teams to synchronize promotional strategies with regulatory obligations and business goals.
  • Design Consultation: Provide regulatory insights during product design and development, ensuring compliance considerations are integrated from the beginning.
  • Post-Market Oversight: Supervise post-market surveillance to guarantee the safety and compliance of marketed devices, including incident reporting and recalls.
  • Adverse Event Management: Oversee the monitoring and reporting of adverse events and product complaints to the relevant regulatory authorities.
  • Audit Support: Prepare for and assist with post-market compliance audits and inspections.
  • Training and Development: Offer regulatory training and guidance to internal teams on international regulatory requirements and updates.
  • Stakeholder Communication: Engage with international regulatory bodies to facilitate processes and address inquiries, fostering positive relationships.
  • Management Reporting: Provide regular updates to management regarding international regulatory affairs and lead data collection efforts.
  • Results-Oriented Execution: Manage the tactical implementation of both short- and long-term objectives, ensuring accountability for outcomes.
  • Interpersonal Skills: Exhibit strong interpersonal skills and a proactive approach to motivating team members.
  • Positive Attitude: Maintain a focused, target-driven mindset with a constructive outlook.
  • Additional Duties: Perform other responsibilities as assigned.

Qualifications:

  • Bachelor's degree in Life Sciences, Regulatory Affairs, or a related discipline; a Master's degree is preferred. RAPS-RAC certification is advantageous.
  • 5-8 years of experience in regulatory affairs, particularly with Class II or Class III medical devices, emphasizing advertising, promotion, and standards review.
  • Demonstrated expertise in regulatory submissions and registrations across various markets.
  • In-depth knowledge of FDA and international regulatory standards, including ISO 13485 and risk management related to medical devices.
  • Proven project management capabilities.
  • Exceptional organizational skills with the ability to manage multiple projects and deadlines efficiently.
  • Strong communication and interpersonal skills, with the ability to collaborate effectively across diverse cultures and regions.
  • Capacity to thrive in a fast-paced, dynamic environment.
  • Excellent presentation and written communication skills.
  • Ability to produce clear, concise, and well-structured technical documentation.

Additional Requirements:

  • Adherence to all company policies and procedures is expected.
  • Compliance with all applicable legal and regulatory requirements related to the product lines and markets is mandatory.

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.