Manager/Sr. Manager, Regulatory Affairs - Pulmonx Corporation
San Jose, CA 95113
About the Job
Company Overview
Pulmonx is a Global Leader in Interventional Pulmonology, Planning Tools, and Treatments for Obstructive Lung Disease. Based in Redwood City, California, and Neuchâtel, Switzerland, Pulmonx is the maker of the Zephyr® Valve. The Zephyr Valve was granted breakthrough status and approved by the FDA in June 2018, because according to the FDA it “represents a breakthrough technology as the device offers 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.”
Will consider Sr. Manager depending upon experience.
Workplace type: Hybrid (will consider Remote for candidates in the Western US)
Position Overview
As the Manager/Senior Manager of Regulatory Affairs at Pulmonx, this role will have responsibilities for advertising and promotion, ensuring that all marketing materials comply with relevant regulations. Key responsibilities include developing and reviewing promotional content, advising on advertising strategies, and collaborating with Legal and commercial teams to align regulatory and promotional efforts while maintaining compliance with international standards. Additionally, this position will oversee all regulatory aspects of devices marketed and sold in international markets, with a specific focus on OUS, Japan, China, and Korea. The role is essential for ensuring that all products meet regulatory requirements and for assisting with international regulatory strategy.
Responsibilities and Capabilities:
- Ensure that all marketing materials and promotional campaigns comply with relevant regulations. Develop and review promotional content to ensure clarity, accuracy, and compliance.
- Review and approve marketing, advertising, promotional items, and labeling for regulatory compliance.
- Collaborate closely with Legal and commercial teams to align regulatory and promotional activities
- Development and implementation of international regulatory strategies. Monitor changes in regulations and assess their impact on product compliance.
- Lead and enable strong cross-functional partnership between Regulatory Affairs and all key stakeholders including Engineering, Product Management, Quality Compliance, Clinical Affairs and other functions at all levels within the business.
- Oversee all regulatory aspects of devices marketed in international markets, focusing on OUS, Japan, China, and Korea and expansion to new countries.
- Ensure products are brought to market on time, and sustained throughout life cycle via compliant, innovative regulatory strategies
- Maintain accurate documentation of regulatory submissions, approvals, and compliance activities.
- A self-starter, motivated and able to positively motivate others.
- Focused, target driven with a positive, can-do attitude.
- Other duties as assigned.
Requirements:
- Minimum of 8 years of experience in regulatory affairs, specifically with Class II or Class III medical devices, focusing on international regulatory support. Experience in a management or leadership role is preferred. Bachelor’s degree in a Life Science is required.
- Experience authoring technical reports, business correspondence and standard operating procedures
- Proven communication skills. Experience presenting clearly and persuasively to technical, non-technical, and regulator audiences
- Extensive knowledge of a broad set of regulations, standards and guidance for medical devices (MDR, MEDDEV, MDCG, IMDRF, FDA QSR, SaMD, cybersecurity, ISO 13485, ISO 14971, IEC 62304, etc.)
Preferred Qualifications
- RAC Certification
Other Requirements:
General:
- The person will be expected to follow and support all Company policies and procedures.
- The person must ensure their activities and those of their staff are in compliance with all legal and regulatory requirements applicable to the product lines and markets in which the Company participates.
When joining Pulmonx, you are part of an organization that attracts and hires the best talent on the planet! You will be working with a great team of dedicated, friendly and collaborative individuals, developing novel and game changing product(s). We are dedicated to the development and growth of our colleagues.
Please note that an application and resume must be completed and submitted for consideration for this opportunity.
Pulmonx Corporation is an Equal Opportunity Employer and embraces diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any characteristic protected by applicable law.
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