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Lead Regulatory Affairs Expert

2 months ago

Redwood City, California, United States Pulmonx Corporation Full time

Company Overview

Pulmonx 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 advancements in non-surgical lung volume reduction.

Position Summary

The Senior Regulatory Affairs Specialist will play a vital role in supporting essential regulatory functions within the organization. This position is tasked with ensuring that all marketing materials associated with medical devices adhere to FDA regulations, international standards, and internal policies. The role is critical in maintaining regulatory compliance through detailed evaluations of marketing communications, labeling, and promotional activities.

Key Responsibilities:

  • Material Review: Conduct comprehensive assessments of promotional content, including digital and print media, to verify compliance with regulatory standards.
  • Regulatory Submissions: Prepare and manage regulatory submissions for product approvals in both domestic and international markets, ensuring timely processing.
  • Strategic Compliance: Formulate and execute regulatory strategies for promotional content to enhance product visibility while ensuring adherence to regulations.
  • Compliance Monitoring: Stay informed about international regulatory requirements and implement necessary adjustments to maintain compliance.
  • Collaboration: Partner with marketing, legal, and clinical teams to ensure alignment of promotional strategies with regulatory obligations.
  • Design Consultation: Provide regulatory insights during product development phases to ensure compliance is integrated from the beginning.
  • Post-Market Oversight: Supervise post-market activities to ensure ongoing compliance and safety of marketed products, including incident reporting.
  • Adverse Event Management: Oversee the monitoring and reporting of adverse events to relevant regulatory bodies.
  • Audit Support: Assist in preparing for compliance audits and inspections.
  • Training and Development: Offer regulatory training and guidance to internal teams regarding international requirements.
  • Stakeholder Relations: Engage with regulatory authorities to facilitate processes and maintain effective communication.
  • Reporting: Provide regular updates to management and compile data specific to International Regulatory Affairs.
  • Project Management: Manage the execution of objectives through coordinated activities with a focus on achieving results.
  • Interpersonal Skills: Exhibit strong interpersonal skills and the ability to motivate team members positively.
  • Proactive Attitude: Demonstrate a focused, target-driven approach with a positive mindset.
  • 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 and Promotion.
  • Proven track record in regulatory submissions across various markets.
  • In-depth knowledge of FDA and international regulatory standards, including ISO 13485.
  • Strong project management capabilities.
  • Exceptional organizational skills to manage multiple projects and deadlines.
  • Excellent communication and interpersonal skills for effective collaboration.
  • Able to thrive in a fast-paced, dynamic environment.
  • Strong written and verbal communication skills.
  • Proficient in creating clear and concise technical documentation.

Additional Expectations:

  • Adhere to all company policies and procedures.
  • Ensure compliance with all legal and regulatory requirements relevant to the company's product lines and markets.

At Pulmonx, we are committed to fostering a diverse and inclusive workplace. We welcome applications from all qualified individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.