# Vice President, MedTech Cardiovascular Regulatory Affairs

**Company**: IQVIA MedTech
**Experience**: senior
**Job type**: full-time
**Salary**: $169,200.00 - $471,500.00
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Washington-DC-United-States-of-America/Vice-President--MedTech-Cardiovascular-Regulatory-Affairs_R1544862-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_419c8a32-a8a

## Description

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.

**Responsibilities and Duties**

- Manage and grow department/team, including budgets, client relationships, employee training and development, hiring, and business development.

- Develop and execute regulatory services for client companies, including regulatory submissions, regulatory strategy, analysis and development.

- Manage Regulatory Affairs staff across multiple services and/or domains, facilitate professional development, and ensure regulatory projects are completed accurately and on time.

- Lead prospecting and be known externally for thought leadership in your 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.

- 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.

**Required Knowledge, Skills, and Experience**

- 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.

- 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.

- Understanding of clinical research and data analysis.

- 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 ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

- Strong written and verbal communication and presentation skills.

- Understanding of engineering and biological background to assist with pre-clinical and clinical strategies.

- Ability to creatively think through potential solutions and effectively communicate them.

- 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 be accountable for team reaching target utilization.

- 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.

**Benefits**

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.

## Skills

### Required
- Regulatory Affairs
- Medical Devices
- Clinical Research
- Data Analysis
- Leadership
- Project Management
- Communication
- Problem-Solving

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Washington-DC-United-States-of-America/Vice-President--MedTech-Cardiovascular-Regulatory-Affairs_R1544862-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)