Senior Regulatory Affairs Specialist
Company: Pulmonx Corporation
Location: Redwood City
Posted on: October 31, 2024
Job Description:
Pulmonx is a Global Leader in Interventional Pulmonology,
Planning Tools, and Treatments for Obstructive Lung Disease. Based
in Redwood City, California, and Neuch--tel, 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 OverviewThe 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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Keywords: Pulmonx Corporation, Redwood City , Senior Regulatory Affairs Specialist, Other , Redwood City, California
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