Vice President, MedTech Cardiovascular Regulatory Affairs

IQVIA•Washington, DC

About The Position

The Vice President, MedTech Cardiovascular Regulatory Affairs will be a critical team member and Company leader supporting regulatory strategy and submissions for the firm’s clientele, and managing and leading their domain specific department, as required. The primary roles and responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, and communicating with regulatory bodies and clients. VPs also manage various personnel during various projects, as well as act as a mentor and trainer for junior employees.

Requirements

Bachelor’s degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred.
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.
Minimum of three to five years of experience managing people related to regulatory affairs or biomedical research and development projects.
Experience with leadership responsibilities for numerous projects and functioning as primary contact for regulatory bodies and clients.
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.
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.
Ability to lead small or large teams effectively, mentor junior team members, and is accountable for team reaching target utilization, as required.
Able to lead multiple projects with competing deadlines; takes initiative and ownership of results; demonstrates a high-level of self-accountability.
Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.
PC/Technical skills- MS Office, Excel, Word, PowerPoint.
Must be punctual, polished, and professional.
Effective interpersonal skills: shows confidence with subject matter and “calm under pressure” approach and style.

Nice To Haves

Knowledge and experience utilizing research evidence and providing statistical analysis is advantageous.

Responsibilities

Manage and grow department/team, including budgets, client relationships, employee training and development, hiring, and business development, as required.
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 across multiple services and/or domains, facilitate professional development, and ensure regulatory projects are completed in an accurate and timely manner.
Leads prospecting of the organization and is known externally for thought leadership in area of expertise.
Lead/manage business development functions to secure new clients and projects.
Work directly with client companies and/or regulatory bodies as primary contact.
Provide project leadership on complex regulatory projects while maintaining sole relationship with client companies.
Lead people development projects, working alongside team managers, as required.
Collaborate with other MCRA departments, including clinical, RHEMA, compliance, and quality assurance.
Collaborate with other department heads and executive management to guide progress and development of the regulatory department and company, as required.