{"data":{"company":{"name":"IQVIA MedTech","slug":"iqvia-medtech","logo_url":"https://logos.yubhub.co/jobs.iqvia.com.png","canonical_domain":"jobs.iqvia.com","editorial":null,"wikidata_id":null,"founded":null,"ceo":null,"founders":[],"hq_location":null,"industry":null,"employee_count":null,"official_website":null,"wikipedia_url":null,"stock_ticker":null,"stock_price":null,"market_cap":null,"revenue":null,"ipo_date":null,"sector":null,"full_time_employees":null,"company_description":null,"twitter_username":null,"linkedin_id":null,"instagram_username":null,"facebook_id":null,"parent_org":null,"country":null,"github_org":null,"github_public_repos":null,"github_followers":null,"github_verified":0,"github_description":null,"github_location":null,"github_blog":null,"github_twitter":null,"stock_exchange":null,"stock_beta":null,"stock_range":null,"stock_is_actively_trading":null,"fmp_image":null,"fmp_address":null,"fmp_city":null,"fmp_state":null,"fmp_country":null,"recent_news":[],"search_interest_index":null,"search_interest_trend":null,"wikipedia_monthly_views":null,"hn_mention_count":null,"hn_top_stories":[],"wayback_first_year":null,"sec_incorporation_state":null,"sec_latest_filing_type":null,"sec_latest_filing_date":null,"sec_filings":[],"research_papers_count":null,"research_citations_count":null,"research_h_index":null,"research_topics":[],"is_federal_contractor":null,"earnings_calendar":[],"industry_canonical":null,"enrichment_sources":[],"last_enriched_at":null},"hiring":{"total_jobs":5,"categories":[{"category":"healthcare","count":5}],"experience_levels":[{"level":"senior","count":3},{"level":"mid","count":1},{"level":"entry","count":1}],"work_arrangements":[{"arrangement":"hybrid","count":1}],"top_titles":[{"title":"VP/Senior Director, Regulatory Affairs - 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$123,000.00.</p>","enriched_at":1793692715745},{"id":"job_b62e4d2d-8ed","title":"VP/Senior Director, Regulatory Affairs - Neurology MedTech","source_url":"https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Washington-DC-United-States-of-America/VP--Neurology-Regulatory-Affairs_R1565011","location":"Washington, DC","job_type":"full-time","experience_level":"senior","work_arrangement":null,"category":"Healthcare","description":"<p>MCRA is part of IQVIA MedTech, a trusted CRO and advisory partner for the medical device and diagnostics industry. The VP/Senior Director, Regulatory Affairs - Neurology MedTech will be a critical team member supporting regulatory strategy and submissions for the firm&#39;s clientele.</p>\n<p>The primary roles and responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, communicating with regulatory bodies and clients, and leading or expanding new therapy ideas. The projects may be for companies in MCRA therapeutic areas, other MCRA areas of regulatory and scientific expertise, and/or other growing therapeutic concentrations of MCRA.</p>\n<p>The VP will also manage various personnel during various projects, as well as act as a mentor and trainer for junior employees.</p>\n<p>Responsibilities and Duties:</p>\n<ul>\n<li>Develop and execute regulatory services for client companies</li>\n<li>Manage regulatory submissions, including 510(k), IDE, PMA, IND, BLA, &amp; IND, Technical Documentation, STED, CERs</li>\n<li>Develop regulatory strategy, analysis, and development</li>\n<li>Design, review, and implement pre-clinical testing</li>\n<li>Manage Regulatory Affairs staff and facilitate professional development</li>\n<li>Lead/manage business development functions to secure new clients and projects</li>\n<li>Develop project and departmental budgets and timelines</li>\n<li>Work directly with client companies and/or regulatory bodies without oversight</li>\n<li>Provide project leadership while maintaining sole relationship with client companies</li>\n<li>Lead people development projects</li>\n<li>Work collaboratively with other MCRA departments</li>\n</ul>\n<p>Required Knowledge, Skills, and Experience:</p>\n<ul>\n<li>Education: Bachelor&#39;s degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred</li>\n<li>Experience: Neurology medical device experience required. Minimum fifteen years of experience in Regulatory Affairs related to development of medical devices, drugs and/or biologics</li>\n<li>Understanding of clinical research and data analysis is required</li>\n<li>Possesses US and/or International regulatory experience/fluency with regulations (e.g., FDA, Notified Body, ISO 13485)</li>\n<li>Strong attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors</li>\n<li>Possesses strong written and verbal communication and presentation skills</li>\n<li>Possesses an understanding of engineering and a biological background</li>\n<li>Able to creatively think through potential solutions and put the solution skillfully on paper</li>\n<li>Strong research, analytical, critical-thinking, and problem-solving skills</li>\n<li>Strong professionalism with customer relations and managing client relationships</li>\n</ul>\n<p>The potential base pay range for this role, when annualized, is $159,600.00 - $444,600.00.</p>","enriched_at":1793156389036},{"id":"job_419c8a32-a8a","title":"Vice President, MedTech Cardiovascular Regulatory Affairs","source_url":"https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Washington-DC-United-States-of-America/Vice-President--MedTech-Cardiovascular-Regulatory-Affairs_R1544862-1","location":"Washington, DC","job_type":"full-time","experience_level":"senior","work_arrangement":null,"category":"Healthcare","description":"<p>We are seeking a Vice President, MedTech Cardiovascular Regulatory Affairs to join our team. As a critical team member and company leader, you will support regulatory strategy and submissions for our clients and manage and lead your domain-specific department.</p>\n<p><strong>Responsibilities and Duties</strong></p>\n<ul>\n<li>Manage and grow department/team, including budgets, client relationships, employee training and development, hiring, and business development.</li>\n<li>Develop and execute regulatory services for client companies, including regulatory submissions, regulatory strategy, analysis and development.</li>\n<li>Manage Regulatory Affairs staff across multiple services and/or domains, facilitate professional development, and ensure regulatory projects are completed accurately and on time.</li>\n<li>Lead prospecting and be known externally for thought leadership in your area of expertise.</li>\n<li>Lead/manage business development functions to secure new clients and projects.</li>\n<li>Work directly with client companies and/or regulatory bodies as primary contact.</li>\n<li>Provide project leadership on complex regulatory projects while maintaining sole relationship with client companies.</li>\n<li>Collaborate with other MCRA departments, including clinical, RHEMA, compliance, and quality assurance.</li>\n<li>Collaborate with other department heads and executive management to guide progress and development of the regulatory department and company.</li>\n</ul>\n<p><strong>Required Knowledge, Skills, and Experience</strong></p>\n<ul>\n<li>Bachelor&#39;s degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred.</li>\n<li>Minimum fifteen years of experience in Regulatory Affairs related to development of medical devices, drugs and/or biologics, developing regulatory deliverables and submissions.</li>\n<li>Minimum of three to five years of experience managing people related to regulatory affairs or biomedical research and development projects.</li>\n<li>Experience with leadership responsibilities for numerous projects and functioning as primary contact for regulatory bodies and clients.</li>\n<li>Understanding of clinical research and data analysis.</li>\n<li>Possesses US and/or International regulatory experience/fluency with regulations (e.g., FDA, Notified Body, ISO 13485).</li>\n<li>Domain-specific regulatory expertise in a therapeutic area or other MCRA areas of regulatory and scientific expertise.</li>\n<li>Strong attention to detail and ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.</li>\n<li>Strong written and verbal communication and presentation skills.</li>\n<li>Understanding of engineering and biological background to assist with pre-clinical and clinical strategies.</li>\n<li>Ability to creatively think through potential solutions and effectively communicate them.</li>\n<li>Strong research, analytical, critical-thinking and problem-solving skills.</li>\n<li>Strong professionalism with customer relations and managing client relationships.</li>\n<li>Ability to lead small or large teams effectively, mentor junior team members, and be accountable for team reaching target utilization.</li>\n<li>Able to lead multiple projects with competing deadlines; takes initiative and ownership of results; demonstrates a high-level of self-accountability.</li>\n<li>Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.</li>\n<li>PC/Technical skills- MS Office, Excel, Word, PowerPoint.</li>\n</ul>\n<p><strong>Benefits</strong></p>\n<p>The potential base pay range for this role, when annualized, is $169,200.00 - $471,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.</p>","enriched_at":1793141840950},{"id":"job_76a63c62-8c9","title":"Director, Regulatory Affairs","source_url":"https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Washington-DC-United-States-of-America/Director--Regulatory-Affairs---Regenerative-Medicine---Biologics-Quality_R1537091","location":"Washington, DC","job_type":"full-time","experience_level":"senior","work_arrangement":null,"category":"Healthcare","description":"<p>We are seeking a Director, Regulatory Affairs to join our team at IQVIA MedTech, a trusted CRO and advisory partner for the medical device and diagnostics industry. As a critical team member, you will support regulatory strategy and submissions for our clients.</p>\n<p>The primary roles and responsibilities include managing the development of regulatory submissions, developing overall regulatory strategy, communicating with regulatory bodies and clients, and leading or expanding new therapy ideas. You will also manage various personnel during projects, act as a mentor and trainer for junior employees, and work directly with client companies and/or regulatory bodies without oversight.</p>\n<p>Key responsibilities:</p>\n<ul>\n<li>Develop and execute regulatory services for client companies, including regulatory submissions, regulatory agency interactions, regulatory strategy, analysis and development, and product classification and jurisdiction</li>\n<li>Manage Regulatory Affairs staff, facilitate professional development, and ensure regulatory projects are completed accurately and on time</li>\n<li>Lead/manage business development functions to secure new clients and projects</li>\n<li>Develop project and departmental budgets and timelines as required</li>\n<li>Work collaboratively with other MCRA departments, including clinical, reimbursement, and quality assurance</li>\n</ul>\n<p>Requirements:</p>\n<ul>\n<li>Bachelor&#39;s degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred</li>\n<li>Minimum five years of experience in Regulatory Affairs related to FDA oversight of various human medical products</li>\n<li>Understanding of FDA regulations, clinical development, and data analysis</li>\n<li>Possesses US and/or International regulatory experience/fluency with regulations, standards, and guidance documents</li>\n<li>Domain-specific regulatory expertise in regenerative medicine or other MCRA areas of regulatory and scientific expertise</li>\n<li>Strong attention to detail, ability to work individually and within a multi-disciplinary team, and strong written and verbal communication skills</li>\n</ul>\n<p>Benefits:</p>\n<ul>\n<li>Competitive salary: $135,300.00 - $376,800.00 per year</li>\n<li>Incentive plans, bonuses, and/or other forms of compensation may be offered</li>\n<li>A range of health and welfare and/or other benefits</li>\n</ul>","enriched_at":1793141650120},{"id":"job_48f06b2d-985","title":"Clinical Research Monitor","source_url":"https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Washington-DC-United-States-of-America/Clinical-Research-Associate-II---MedTech_R1571271","location":"Washington, DC","job_type":"full-time","experience_level":"mid","work_arrangement":null,"category":"Healthcare","description":"<p>We are seeking a Clinical Research Monitor to join our team at IQVIA MedTech, a trusted CRO and advisory partner for the medical device and diagnostics industry.</p>\n<p>The successful candidate will perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.</p>\n<p><strong>Essential Functions</strong></p>\n<ul>\n<li>Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines</li>\n<li>Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability</li>\n<li>Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues</li>\n<li>Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations</li>\n<li>Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution</li>\n<li>Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator&#39;s Site File (ISF) is maintained in accordance with GCP and local regulatory requirements</li>\n<li>Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation</li>\n<li>Collaborate and liaise with study team members for project execution support as appropriate</li>\n</ul>\n<p><strong>Qualifications</strong></p>\n<ul>\n<li>Bachelor&#39;s Degree in a scientific discipline or health care preferred</li>\n<li>At least 1 year of on-site monitoring experience</li>\n<li>Equivalent combination of education, training and experience may be accepted in lieu of degree</li>\n<li>Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)</li>\n<li>Good therapeutic and protocol knowledge as provided in company training</li>\n<li>Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)</li>\n<li>Written and verbal communication skills including good command of English language</li>\n<li>Organizational and problem-solving skills</li>\n<li>Effective time and financial management skills</li>\n<li>Ability to establish and maintain effective working relationships with coworkers, managers, and clients</li>\n</ul>\n<p><strong>Salary</strong> The potential base pay range for this role, when annualized, is $90,200.00 - 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