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.”
Position Overview
The Sr. Regulatory Affairs Specialist will be responsible for assisting and supporting core regulatory affairs activities for the business, in addition to supporting advertising, promotional and standards review. This position will ensure that all promotional materials related to the medical devices marketed and sold comply with FDA regulations, international requirements and company policies. This position plays a crucial role in ensuring regulatory compliance by meticulously reviewing marketing communications, labeling, and promotional practices.
Responsibilities and Capabilities:
- Review and Approval: Conduct thorough reviews of advertising and promotional materials, including digital content, print media, and public relations messages, to ensure compliance with FDA regulations and industry standards.
- Submission and Approvals: Prepare and submit regulatory dossiers for product registration in international and/or US markets. Manage all aspects of the submission process to ensure timely approval of products.
- Regulatory Strategy: Develop and implement regulatory strategies for promotional materials to optimize product positioning while ensuring compliance.
- Regulatory Compliance: Monitor and ensure compliance with all international regulatory requirements and changes. Adapt strategies and processes as needed to maintain compliance.
- Cross-functional Collaboration: Work closely with the marketing, legal, and clinical teams to align promotional strategies with regulatory requirements and business objectives.
- Regulatory Input in Design: Provide expert regulatory advice during the product design and development phases, ensuring regulatory considerations are integrated into product planning from the outset.
- Market Surveillance: Oversee post-market surveillance activities to ensure ongoing compliance and safety of marketed devices. Handle incident reporting and recalls in coordination with local authorities.
- Adverse Event Reporting: Oversee the monitoring and reporting of adverse events and product complaints to regulatory authorities in the applicable International Regions.
- Audit Preparation: Prepare and support post-market compliance audits and inspections.
- Training and Guidance: Provide regulatory guidance and training to internal teams and stakeholders on international regulatory requirements and changes.
- Stakeholder Engagement: Liaise with international regulatory authorities and bodies to facilitate processes and address queries. Build and maintain positive relationships with regulatory representatives.
- Communication: Provide regular updates to the management team and lead and collate data specific to International Regulatory Affairs for the organization.
- Manage the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results.
- Excellent interpersonal skills.
- A self-starter, motivated and able to positively motivate others.
- Focused, target driven with a positive, can-do attitude.
- Other duties as assigned.
Requirements:
- Bachelor's degree in Life Sciences, Regulatory Affairs, or related field. Master's Degree preferred. RAPS-RAC preferred.
- Minimum of 5-8 years' experience working in a regulatory affairs role, specifically with Class II or Class III medical device experience, with depth in Advertising and Promotion and Standards review.
- Proven experience in regulatory submissions and registrations across multiple markets.
- Strong understanding of FDA and international regulatory standards, including ISO 13485 and risk management processes related to medical devices.
- Demonstrated project management skills and experience.
- Excellent organizational skills, with the ability to manage multiple projects and timelines effectively.
- Strong communication and interpersonal skills, capable of working collaboratively across cultures and geographies.
- Ability to work effectively in a fast-paced and dynamic environment.
- Strong presentation skills, written and verbal communication skills required.
- Ability to write clear, concise, and well-thought-out technical documents.
Other Requirements:
- 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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