What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at PulmonX Corporation?
Pulmonx is looking for a Sr Regulatory Affairs Specialist to join our team supporting all regulatory aspects of our groundbreaking medical devices. Your expertise will be crucial in ensuring that all products meet US and international regulatory requirements for our current and future markets. If you enjoy a mix of both tactical and strategic hands-on work with a strong group of Regulatory Affairs experts, please apply!
Location: Remote (or hybrid opportunity in the Bay Area if you prefer!), but working West Coast Hours is required.
Responsibilities and Capabilities:
- Manage all regulatory activities related to the registration and compliance of medical devices in US and rest of the world
- Ensure that all products comply with relevant regulations and standards throughout the product lifecycle.
- Develop and implement international regulatory strategies to facilitate market entry and product approvals.
- Collaborate cross-functionally with teams in Commercial, Marketing, Quality Assurance, and Legal to ensure alignment on regulatory matters.
- Monitor and analyze changes in international regulations and assess their impact on existing and future products.
- Prepare and submit regulatory documentation to regulatory authorities in target markets.
- Lead and participate in meetings with regulatory authorities, as needed, to advocate for Pulmonx products and clarify regulatory positions.
- Maintain accurate records and documentation of regulatory submissions and communications with regulatory bodies. Stay current with industry trends and best practices in international regulatory affairs.
- Excellent interpersonal skills, Focused, target driven with a positive, can-do attitude.
- Other duties as assigned.
Requirements:
- Bachelor's degree or equivalent combination of education and work experience required.
- Minimum of 3-5 years of experience in regulatory affairs, specifically with Class II or Class III medical devices.
- 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.)
Compensation: $105,000 - $145,000 depending on experience
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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Salary : $105,000 - $145,000