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Regulatory Affairs Director
2 months ago
We are seeking a highly experienced Regulatory Affairs Director to join our team at Pulmonx Corporation. As a key member of our leadership team, you will be responsible for implementing regulatory strategies worldwide to ensure compliance with regulatory requirements and obtain regulatory approval for our products.
Key Responsibilities- Regulatory Strategy and Compliance
- Develop and implement regulatory strategies to ensure compliance with global regulatory requirements.
- Oversee the preparation of regulatory submissions for global regulatory agencies.
- Manage global licensing and product registration of new products and enhancements to existing products.
- Quality Assurance and Compliance
- Oversee compliance to quality regulations and standards.
- Direct activities of the Quality Assurance team during facility inspections and audits of the Pulmonx Quality System.
- Regulatory Affairs and Quality Management
- Define and lead the Regulatory and Quality strategies for the company.
- Act as a liaison to the FDA and ensure timely responses to regulatory agency inquiries.
- Direct activities of the Regulatory team at Pulmonx headquarters during preparation of technical and scientific documents and dossiers intended for review by regulatory authorities.
- Leadership and Collaboration
- Lead all ancillary regulatory functions (e.g. promotional material review, labeling, etc.) for the expressed purpose of delivering timely and cost-effective services to internal customers.
- Collaborate with senior managers to establish and implement company policies to assure ongoing compliance with regulatory requirements.
- Bachelor's Degree required, preferably related to Regulatory Affairs, Quality Assurance, Life Sciences, Legal and/or Engineering disciplines.
- Regulatory Affairs (R.A.C.) credential is strongly desired.
- Minimum of 12 years' experience in advanced medical device RA/QA is required, with at least 5 years management experience therein.
- Experience with Class III and Class II medical devices and implantable products desired.
- Strong negotiating skills and an ability to ensure that Pulmonx will pursue full compliance with all applicable regulatory and quality guidelines.
- A 'hands-on' approach to achieving and producing expected results, and therefore includes proficiency at using industry-standard PC software programs including database systems as tools.
- Excellent written, verbal, and interpersonal communication skills.
- Must be available to travel as required to effectively perform all functions of the position.
