Associate Director, Regulatory Affairs

Neptune Medical, is an innovative, venture capital funded medical device startup headquartered in Burlingame, CA. We have already commercialized novel medical devices using our technology. Now the team at Neptune is building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy. Triton Robotic Endoscopy will disrupt flexible endoscopy and set a new standard in outcomes for decades to come. TITLE: Senior Manager of Clinical Affairs POSITION SUMMARY: The Clinical Affairs Senior Manager/Associate Director will be responsible for the design, execution and monitoring of clinical studies and will provide scientific expertise throughout the development and implementation of the studies. This role is accountable for the end-to-end clinical strategy, design, execution, oversight, and reporting of clinical studies supporting product development, regulatory submissions, and commercialization. S/he will work closely with R&D, Regulatory Affairs, Quality and external stakeholders to ensure high-quality, compliant, and efficient clinical programs and interact with regulatory agencies as needed to support regulatory submissions and audits. The ideal candidate would act with passion and intensity in a medical device start-up that is fast paced and collaborative and display the ability to perform to the requirements outlined below. For the right person, this position will be a tremendously exciting and career-defining opportunity, offering the opportunity to shape clinical strategy for a novel medical robotic platform and to contribute meaningfully to the company’s long-term success. ROLES AND RESPONSIBILITIES: Clinical Strategy and Leadership Lead the development and execution of the overall clinical strategy aligned with company and regulatory objectives. Provide expert input into clinical development plans, trial design, and evidence-generation strategies across the product lifecycle. Advise senior leadership

Position Summary We are seeking a strategic, analytical, and highly collaborative leader to serve as our Associate Director/Senior Manager of Health Economics & Outcomes Research (HEOR) Oncology. In this high-impact role, you will lead the development and execution of health economic and outcomes evidence demonstrating the clinical and economic value of Natera’s precision molecular diagnostic technologies across oncology and emerging indications. You will develop health economic models, generate real-world and clinical-trial evidence, lead HEOR publication initiatives, and translate complex clinical and economic data into compelling evidence supporting market access, reimbursement, payer adoption, clinical adoption, and commercialization. Working across Medical Affairs, Clinical Development, Biostatistics, Market Access, Commercial, Marketing, Regulatory, and Business Development, you will help integrate HEOR evidence throughout the product lifecycle—from clinical development and evidence generation through publication, reimbursement, and payer adoption. This is a strategic role for an experienced HEOR professional who combines strong technical capabilities with scientific communication, business acumen, and the ability to influence cross-functional evidence strategy. Why Join Us At Natera, you will have the opportunity to shape the economic evidence strategy supporting innovative precision diagnostics and biomarker-guided approaches to patient care. You will work at the intersection of clinical evidence, health economics, market access, and commercialization, translating clinical innovation into measurable value for patients, providers, health systems, and payers. You will collaborate with internal leaders, investigators, key opinion leaders, and external research partners to generate evidence capable of influencing reimbursement decisions, clinical adoption, health technology assessments, and healthcare policy across U.S. and global markets. Key Responsibiliti

Dear Candidate We have immediate vacancies for the post of Chemist, Microbiologist, Production, Quality Assurance, Quality Control, Regulatory Affairs, R & D, Pharma, Research Associate, Lab Asst. Qualification : BSc / MSc Freshers and Experienced Salary : 4 Lakhs Per Annum to 9 LPA Contact Mr Vasanth Managing Director 7353549756 / 8722187029 Karnataka Information Solution No.6, Basement Floor, ASVNV Bhavan, Opp State Bank Of India, K.G Road, Majestic, Bangalore - 09 PH : 080 - 22260106.

As the Associate/Laboratory Director, you have clinical oversight of Natera’s laboratory testing. You ensure that testing is properly performed, and applicable regulatory standards are met. You are responsible for ensuring that the laboratory implements testing while consistently providing accurate and reliable patient test results. PRIMARY RESPONSIBILITIES: Review, approve, and sign-out reports for a variety of clinical molecular/cytogenetic and/or oncologic results, including NIPT, carrier screening, PGD/PGS, products of conception and rare disease testing on platforms including SNP array analysis, NGS, and other methodologies. Oversee the review of genetic and CNV variant data: interpret NGS and microarray results in the context of medical literature, online variant databases and other references along with relevant patient demographic data. Provide clinical and technical support for genetic counselors and other laboratory personnel. Set standards for laboratory testing and acceptable levels of analytic performance and ensure these are maintained. Analyze lab data, contribute to or write publications for high-quality scientific journals. May serve as Technical Supervisor. The Technical Supervisor is responsible for ensuring: appropriate test method selection; adequate method verification to determine the accuracy and precision of the test; enrollment of the laboratory in a CMS-approved proficiency testing (PT) program for the test performed; PT samples are tested in accordance with the CLIA requirements; PT results are returned within the time frames established by the PT program; PT reports are reviewed by the appropriate staff; corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory; quality assessment and quality control programs are established and maintained; acceptable analytical test performance is established and maintained for each test system; remedial actions are taken and documented when signific

As the Associate/Laboratory Director, Oncology and one of our Laboratory Directors, you have clinical oversight of Natera’s laboratory testing. You ensure that testing is properly performed, and applicable regulatory standards are met. You are responsible for ensuring that the laboratory implements testing while consistently providing accurate and reliable patient test results. PRIMARY RESPONSIBILITIES: Review, approve, and sign-out reports for a variety of clinical molecular/cytogenetic and/or oncologic results, including the Signatera MRD assay and other Next Generation Sequencing based assays. Oversee the review of genetic and CNV variant data: interpret NGS results in the context of medical literature, online variant databases and other references along with relevant patient demographic data. Provide clinical and technical support for genetic counselors and other laboratory personnel. Set standards for laboratory testing and acceptable levels of analytic performance and ensure these are maintained. Analyze lab data, contribute to or write publications for high-quality scientific journals. May serve as Technical Supervisor. The Technical Supervisor is responsible for ensuring: appropriate test method selection; adequate method verification to determine the accuracy and precision of the test; enrollment of the laboratory in a CMS-approved proficiency testing (PT) program for the test performed; PT samples are tested in accordance with the CLIA requirements; PT results are returned within the time frames established by the PT program; PT reports are reviewed by the appropriate staff; corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory; quality assessment and quality control programs are established and maintained; acceptable analytical test performance is established and maintained for each test system; remedial actions are taken and documented when significant deviations from the laboratory’s established

Associate/Laboratory Director of Oncology, Comprehensive Genomic Profiling Position Summary As an Associate Lab Director or Lab Director of Oncology, you have clinical oversight of Natera’s laboratory testing related to cancer testing. You ensure that testing is properly performed, and applicable regulatory standards are met. You are responsible for ensuring that the laboratory implements testing while consistently providing accurate and reliable patient test results. You are responsible for ensuring the test validation and development meets all required regulatory standards. This position will be primarily responsible for technical and clinical performance of Natera’s comprehensive genomic profiling (CGP) assays. Title and scope of responsibility will be commensurate with the candidate’s experience. This position is on-site at Natera’s San Carlos, CA Laboratory. Primary Responsibilities Provide clinical sign-out and interpretation for CGP reports, identifying actionable biomarkers and relevant clinical trials Provide technical and clinical support for laboratory staff, genetic counselors, and other clinical personnel Ensure acceptable levels of analytical performance for CGP assays, compliance with applicable standards, and laboratory inspection-readiness at all times Troubleshoot workflow and laboratory issues with clinical care and regulatory standards in mind Document findings and maintain accurate records consistent with Natera policies and procedures May serve as Clinical Consultant . A Clinical Consultant is responsible for ensuring: Test reports include pertinent information for test interpretation, and Availability for consultation concerning test results and the interpretation of those results as they relate to specific patient conditions Qualifications Education: MD/DO and/or PhD in genetics or related field required. Board Certification: ABMGG board-certified in Clinical Cytogenet