Senior Regulatory Affairs Specialist

Description:

We are recruiting for a Regulatory Affairs Specialist to join our IVD new product development team. We seek an innovative and highly motivated leader to develop and lead the implementation of regulatory strategy to expedite the availability of new technology to market, to empower scientists and doctors to transform lives. The role will provide the successful candidate with the opportunity to work in a highly matrixed and collaborative environment

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Job Responsibilities:

• Provides regulatory leadership to IVD product development program teams by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions.
• Assesses regulatory pathways for new products and product modifications; develops regulatory strategies and tactical plans for global submissions.
• Leads and prepares regulatory submissions, such as US PMA, 510(k) submissions, pre-submission, and EU IVDR Technical Documentation, and leads submission process through clearance/approval.
• Coordinates interactions/negotiations with U.S. and EU regulatory agencies as directed.
• Works with business and cross-functional team to ensure alignment of global regulatory strategies with business objectives and implementation of the strategic plans.
• Reviews and approves labels, labeling, and promotional materials.
• Reviews product design and change documentation, performs regulatory assessments, and implements required regulatory actions.
• Reviews analytical and clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.
• Responsible for writing and updating standard operating procedures (SOP) and work instructions (WI).
• Identifies and communicates potential risks and mitigations associated with regulatory strategies.
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions with other members of regulatory and related teams
• Conducts impact assessment of changing regulations and guidance and participates in advocacy.

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Minimum Qualifications:

• Bachelor's degree required, preferred in science and engineering.
• Experience in regulatory affairs in the device/diagnostic industry.
• Demonstrated experience in authoring FDA 510(k), leading pre-submissions, and interacting with FDA to obtain clearance.
• Experience with PMA, IVDR/MDR and IVD experience is a plus.
• Working knowledge of US and EU In Vitro Diagnostic or Medical Device Regulatory requirements.