Pulmonx is looking for an experienced Sr Regulatory Affairs Specialist to join our dynamic Regulatory Affairs Team!
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Responsibilities and capabilities:
Support Product Development & Registration:
Provides regulatory input and technical guidance on global regulatory requirements to product development teams.
Advises stakeholders of regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
Assesses the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable regulations.
Evaluates proposed preclinical, clinical and manufacturing changes for regulatory filing solutions and proposes plans/strategizes for changes that do not require submissions.
Provides knowledge and guidance on preapproval inspections, GCP inspections and clinical investigator relationships.
Identifies, monitors and submits applicable reports (e.g., Serious Adverse Events) or notifications (e.g., changes in manufacturing) to regulatory authorities during the clinical research process.
Provides regulatory information and guidance for proposed product claims/labeling.
Ensures that the clinical and nonclinical data-in conjunction with regulatory strategy-are consistent with the regulatory requirements and support the proposed product claims.
Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.
Works with cross functional teams for interactions with regulatory authorities.
SupportPost-approval/Post-marketActivities:
Develops and implements processes involved with maintaining annual licenses, registrations and listings.
Reviews and approves advertising and promotion to ensure regulatory compliance.
Assures post-market regulatory requirements are met (e.g., required reports, supplemental submissions and other post-marketing commitments.)
Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge.
Participates in implementation of regulatory strategy and processes for handling recalls and communication to stakeholders (e.g., Dear Healthcare Professional letters, patient letters, distributor letters, and health authorities).
Reports product safety issues and reportable events to regulatory authorities as required, to comply with local, regional and global regulations.
Provides required information (e.g., clinical data) in support of product reimbursement requests.
Provides regulatory input and appropriate follow-up for inspections and audits.
Conduct Regulatory Surveillance and Develop Regulatory Strategies
Assesses regulatory intelligence to assist in the development of local, regional and global regulatory strategies.
Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.
Identifies requirements and potential obstacles for market access and distribution (federal, provincial/territorial state, reimbursement, purchasing groups, HTA, etc.).
Assists in the development of regulatory strategy and updates strategy based upon regulatory changes.
Evaluates proposed products for regulatory classification and jurisdiction.
Determines requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities.
Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory unit and other units in the organization.
Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes.
Identifies the need for new regulatory procedures and SOPs and participates in development and implementation.
Helps train stakeholders on current and new regulatory requirements to ensure organization- wide compliance.
Assists other departments in the development of SOPs to ensure regulatory compliance.
Requirements:
Bachelor's degree or equivalent work experience required, Science or Engineering degrees preferred
At least 5 years of regulatory affairs experience in the medical device industry or equivalent experience.
Demonstrated project management skills and experience.
Proficient in timely review of technical data.
Demonstrated success in fast-paced start-up, entrepreneurial work environment.
Ability to write clear, concise, and well thought out technical documents.
Ability to take leadership role in regulatory and/or cross-functional team.
Compensation: $156,000 - $175,000 annual base salary dependent upon experience
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.