- Develop and execute regulatory services for client companies, including however not limited to:
- Regulatory Submissions (e.g., 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs)
- Regulatory Strategy, Analysis & Development
- Design, Review & Implement Pre-Clinical Testing
- Manage Regulatory Affairs staff, facilitate professional development and ensure regulatory projects are completed in an accurate and timely manner.
- Lead/manage business development functions to secure new clients and projects.
- Develop project and departmental budgets and timelines, as required.
- Work directly with client companies and/or regulatory bodies without oversight.
- Provide project leadership while maintaining sole relationship with client companies.
- Lead people development projects, working alongside team managers, as required.
- Work collaboratively with other MCRA departments, including clinical, RHEMA, and quality assurance.
- Work with other department heads and executive management to guide progress and development of the regulatory department and company, as required.
- Education: Bachelor’s degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred.
- Certification/Licensure: Not applicable.
- Experience: Neurology medical device experience required. Minimum fifteen years of experience in Regulatory Affairs related to development of medical devices, drugs and/or biologics, developing regulatory deliverables and submissions. Work experience must include project management and/or managerial experience.
- An understanding of clinical research and data analysis is required.
- Possesses US and/or International regulatory experience/fluency with regulations (e.g., FDA, Notified Body, ISO 13485).
- Domain-specific regulatory expertise in a therapeutic area or other MCRA areas of regulatory and scientific expertise.
- Understanding of your team's regulatory landscape, including the breadth of services, how they interact, and how data flows between deliverables.
- Strong attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong written, including medical/technical writing, and verbal communication and presentation skills.
- Possesses an understanding of engineering and a biological background to assist with pre-clinical and clinical strategies and is able to effectively communicate these strategies to internal team members and clients.
- Able to creatively think through potential solutions and put the solution skillfully on paper.
- Strong research, analytical, critical-thinking and problem-solving skills.
- Strong professionalism with customer relations and managing client relationships.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $159,600.00 - $444,600.00. 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.Skills Required
- Bachelor’s degree in a scientific, engineering, or regulatory discipline
- Neurology medical device experience
- At least 15 years of Regulatory Affairs experience involving medical devices, drugs, and/or biologics
- Experience developing regulatory deliverables and submissions
- Project management and/or managerial experience
- Understanding of clinical research and data analysis
- US and/or international regulatory experience, including FDA, Notified Body, and ISO 13485 requirements
- Domain-specific regulatory expertise in a therapeutic area or related scientific discipline
- Strong medical, technical, written, verbal, communication, and presentation skills
- Strong research, analytical, critical-thinking, and problem-solving skills
- Ability to manage client relationships and work with multidisciplinary teams
- Master’s degree or PhD
IQVIA Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about IQVIA and has not been reviewed or approved by IQVIA.
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Healthcare Strength — Healthcare coverage is positioned as comprehensive, spanning medical/dental/vision plus programs like telemedicine, EAP resources, and additional insurance options. Feedback suggests the health offering is a meaningful part of the overall rewards package, though details can vary by location and plan design.
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Retirement Support — Retirement benefits include an employer match structure that supports employee contributions through a defined formula. This adds steady long-term value to total rewards beyond base salary.
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Leave & Time Off Breadth — Time off offerings include vacation/paid time off, holidays, and flexibility themes, with some roles described as having discretionary or unlimited time-off models. This can make the package feel more attractive even when cash compensation is viewed as only mid-range.
IQVIA Insights
What We Do
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 70,000 employees, IQVIA conducts operations in more than 100 countries. To learn more, visit www.iqvia.com.
