Job Title: Spec 4, Regulatory Affairs
Duration: 6 Months
Location: Milpitas., CA, USA, 95035
Description:
Work days/hours: M - F 8am - 5pm
Hybrid role - 4 days in office/1-day remote work
LOCALS ONLY
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 develop solutions with other members of regulatory and related teams
• Conducts impact assessment of changing regulations and guidance and participates in advocacy.
• Mentor junior staff of regulatory professionals and conduct training on regulatory subject.
• Provides support to Associate Director RA, and performs other related duties and assignments as required.
Minimum Qualifications:
• Bachelor's degree required, preferred in science and engineering
• Minimum 5 years’ experience in regulatory affairs in the device/diagnostic industry. Demonstrated experience in authoring FDA 510(k), leading pre-submissions, and interact 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.
• Demonstrated project management, negotiation, and communication (written and oral) skills to all levels within the organization and external to the organization.
• Demonstrated ability to interpret and implement new regulations and guidance.
• Demonstrated ability to prioritize challenging priorities and deadlines, and organize complex information
• Demonstrated analytical thinking to comprehend and analyze an issue, and resolve problem
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