Lead Regulatory Affairs Expert

1 week ago

Redwood City, California, United States Pulmonx Corporation Full time

Company Overview

Pulmonx 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 significant clinical advantages in treating lung conditions.

Position Summary

The Senior Regulatory Affairs Specialist will play a pivotal role in supporting the regulatory affairs functions of the organization. This position involves ensuring that all marketing materials associated with medical devices adhere to FDA regulations, international standards, and internal policies. The specialist will be integral in maintaining regulatory compliance through detailed evaluations of marketing communications, labeling, and promotional activities.

Key Responsibilities:

  • Material Review: Execute comprehensive evaluations of promotional content, including digital and print media, to confirm adherence to FDA regulations and industry benchmarks.
  • Regulatory Submissions: Prepare and manage regulatory submissions for product registration in both domestic and international markets, ensuring timely approvals.
  • Strategic Compliance: Formulate and implement regulatory strategies for promotional materials, optimizing product visibility while ensuring compliance.
  • Monitoring Compliance: Stay updated on international regulatory requirements and modifications, adjusting strategies as necessary to maintain compliance.
  • Collaborative Efforts: Partner with marketing, legal, and clinical teams to synchronize promotional strategies with regulatory mandates and business goals.
  • Design Input: Offer regulatory insights during product design and development phases, ensuring compliance considerations are integrated from the beginning.
  • Post-Market Surveillance: Supervise post-market activities to guarantee ongoing compliance and safety of marketed devices, including incident reporting and recalls.
  • Adverse Event Management: Oversee the tracking and reporting of adverse events and product complaints to relevant regulatory authorities.
  • Audit Support: Prepare for and assist in post-market compliance audits and inspections.
  • Training and Development: Provide regulatory training and guidance to internal teams on international requirements and updates.
  • Stakeholder Relations: Engage with international regulatory bodies to facilitate processes and address inquiries, fostering positive relationships.
  • Communication: Regularly update management on regulatory affairs, compiling data specific to international regulations.
  • Project Management: Manage the execution of both short- and long-term objectives, coordinating activities with a focus on results.
  • Interpersonal Skills: Exhibit strong interpersonal skills and a proactive, motivating approach.
  • Target Orientation: Maintain a focused, results-driven mindset with a positive attitude.
  • 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 across various markets.
  • In-depth knowledge of FDA and international regulatory standards, including ISO 13485 and risk management processes for medical devices.
  • Proven project management capabilities.
  • Exceptional organizational skills, adept at managing multiple projects and timelines.
  • Strong communication and interpersonal skills, with the ability to collaborate across diverse cultures and regions.
  • Ability to thrive in a fast-paced, dynamic environment.
  • Excellent presentation and technical writing skills.

Additional Requirements:

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

At Pulmonx, we are committed to attracting and retaining top talent, fostering a collaborative and innovative work environment. We value the development and growth of our employees.

Pulmonx Corporation is an Equal Opportunity Employer, promoting diversity and inclusion in the workplace.

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