Description
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's clientele.
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.
The VP will also manage various personnel during various projects, as well as act as a mentor and trainer for junior employees.
Responsibilities and Duties:
- Develop and execute regulatory services for client companies
- Manage regulatory submissions, including 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs
- Develop regulatory strategy, analysis, and development
- Design, review, and implement pre-clinical testing
- Manage Regulatory Affairs staff and facilitate professional development
- Lead/manage business development functions to secure new clients and projects
- Develop project and departmental budgets and timelines
- 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
- Work collaboratively with other MCRA departments
Required Knowledge, Skills, and Experience:
- Education: Bachelor's degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred
- Experience: Neurology medical device experience required. Minimum fifteen years of experience in Regulatory Affairs related to development of medical devices, drugs and/or biologics
- 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)
- 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 and verbal communication and presentation skills
- Possesses an understanding of engineering and a biological background
- 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
The potential base pay range for this role, when annualized, is $159,600.00 - $444,600.00.