Description
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.
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.
Key responsibilities:
- Develop and execute regulatory services for client companies, including regulatory submissions, regulatory agency interactions, regulatory strategy, analysis and development, and product classification and jurisdiction
- Manage Regulatory Affairs staff, facilitate professional development, and ensure regulatory projects are completed accurately and on time
- Lead/manage business development functions to secure new clients and projects
- Develop project and departmental budgets and timelines as required
- Work collaboratively with other MCRA departments, including clinical, reimbursement, and quality assurance
Requirements:
- Bachelor's degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred
- Minimum five years of experience in Regulatory Affairs related to FDA oversight of various human medical products
- Understanding of FDA regulations, clinical development, and data analysis
- Possesses US and/or International regulatory experience/fluency with regulations, standards, and guidance documents
- Domain-specific regulatory expertise in regenerative medicine or other MCRA areas of regulatory and scientific expertise
- Strong attention to detail, ability to work individually and within a multi-disciplinary team, and strong written and verbal communication skills
Benefits:
- Competitive salary: $135,300.00 - $376,800.00 per year
- Incentive plans, bonuses, and/or other forms of compensation may be offered
- A range of health and welfare and/or other benefits