VP of Regulatory & Quality (Medical Devices)

VP of Regulatory & Quality

Industry
Medical Devices
Capital
Undisclosed
Team Size
38

By the Numbers

176
Identified
45
Vetted
10
Introduced
1
Placed
187
Days

The Challenge

The VP of Regulatory & Quality will play a key role by setting the regulatory strategy of the company’s cutting-edge solutions in the marketplace. Collaborating closely with the President and Senior Executive team, the leader will be responsible for developing and executing US strategies and submissions for regulatory clearance of the company’s existing and future products. This seasoned professional will oversee all regulatory and quality information, track and control submissions, review and advise on labeling for compliance with filings, reviews, product changes for impact on regulatory filings worldwide, and research regulatory issues in a collaborative manner to amplify the value of products across the plasma market.

The Mandate

Attributes
Ideal
Domain Expertise
510k experience
Quality Experience
Implemented & created QMS/SOPs
Standard Experience
Experience with IEC 62304
Agency Relationships
Thought leader
Start-up experience
Thrives in agile dev culture
Product Commercialization & Roadmap
Led roadmaps for portfolio expansion
Project Management
Org. skillsets with multiple clearances early
Team Management
5+ years managing teams
Cross Functional Collaboration
Exceptional communicator
Work Location Experience
Work asynchronously

Below is reference to CMS item that will help in CMS Nest by Attributes.
- Reference for Sector
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