FDA Regulatory Attorney – Class III IVD Companion Diagnostics

Role Overview:
We are seeking an experienced FDA Regulatory Attorney with deep hands-on expertise in Class III PMA in vitro diagnostic (IVD) and companion diagnostic products to work with our client a Fortune 500 clinical laboratory. This person will serve as the primary FDA-facing regulatory lead driving strategy and execution for complex submissions and lifecycle management in close partnership with cross-functional and partner teams.

Key Responsibilities:

• Lead FDA regulatory strategy and execution for Class III PMA IVDs and companion diagnostics including lifecycle PMA planning and post-approval changes.
• Own strategy drafting and management of Modular PMAs full PMAs PCCPs Q-Subs SIRs and related submissions.
• Act as the main interface with FDA/CDRH: lead meetings negotiate positions and draft responses to FDA requests for additional information.
• Advise on pre- and post-approval requirements (quality systems risk management MDRs labeling and other post-market obligations).
• Support product classification and premarket strategies for 510(k)-regulated IVDs including Q-Sub preparation.
• Partner with cross-functional teams (BD commercial R&D quality manufacturing legal regulatory) and external partners to align regulatory and business goals.
• Develop and deliver training on FDA regulation of medical devices and IVDs including approvals/clearances and enforcement topics.

Qualifications:

• J.D. and active license to practice law in at least one U.S. jurisdiction.
• At least five years of in-house experience at a medical device or diagnostics company is preferred.
• Direct ownership ofClass III PMA IVD and/or companion diagnostic submissions(strategy drafting and FDA interaction).
• Recent hands-on experience withModular PMAs FDA Q-Subs PCCPs SIRs and lifecycle PMA strategy.
• Strong knowledge of FDA regulations and guidance for Class III PMA devices IVDs and companion diagnostics; familiarity with 510(k) pathways for IVDs preferred.
• Proven ability to act as theprimary FDA-facing regulatory lead work cross-functionally and communicate clearly with technical and business stakeholders.

Compensation Benefits & Location:

This role offers a range of competitive compensation starting at $150000 and a highly competitive benefits package in the alternative legal services marketplace that includes health benefits 401K and more. Axiomites also get access to professional development resources and learning and development programs. Axiomites predominately work remotely with the exception that some clients require on-site presence.

Axiom is the global leader in high-caliber on-demand legal talent. Covering North America the UK Europe and APAC we enable legal departments to drive efficiency and growth and meet the demands of todays business landscape with best in breed alterative legal services.

Axiom is a leader in diversity inclusion and social engagement. Diversity is core to our values and we are proud to be an equal opportunity employer. We are proud to be named a best place to work for LGBTQ Equality earning top marks in the 2021 Corporate Equality Index for the second consecutive year. Axioms legal department is Mansfield certified and is committed to considering at least 50% diverse candidates for leadership roles and outside counsel representation.

Pursuant to the San Francisco Fair Chance Ordinance we will consider for employment qualified applicants with arrest and conviction records.Learn more about working at Axiom.

Equal Opportunity Employer: Axiom ensures equal employment opportunity in recruitment and employment without discrimination or harassment on the basis of race color nationality national or ethnic origin religious creed or belief political opinion sex gender reassignment pregnancy or maternity age disability alienage or citizenship status marital (or civil or other partnership recognized by law) status genetic predisposition or carrier status sexual orientation military service or any other characteristic protected by applicable law. Axiom prohibits and will not tolerate any such discrimination or harassment.

Accommodation for Individuals with Disabilities: Upon request and consistent with applicable laws Axiom will provide reasonable accommodations for individuals with disabilities who require an accommodation to participate in each stage of the recruitment process. To request an accommodation to complete the application form please contact us at and include Applicant Accommodation in the subject line.

Axiom respects your privacy. For an explanation of the kind of information we collect about you and how it is used our full privacy notice is available at with Axiom may be contingent upon successful completion of a background check providing proof of identity and possessing the necessary legal authorization to work.

By submitting an application you acknowledge that all information contained therein and provided at any part of the application process is correct and accurate to the best of your knowledge.

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Required Experience:

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