Vice President, Regulatory Affairs (Hybrid)

Join A Team Committed To Improving Patient Care

It takes a team of talented people to become one of the world's leading providers of innovative medical devices. AngioDynamics is dedicated to improving patient outcomes by focusing on the development of disruptive and differentiated technologies that address unmet patient needs and supporting professional healthcare providers around the world in the delivery of high-quality patient care.

We accomplish this through :

• A Commitment to the Highest Standards of Quality
• Relentless Innovation
• Operational Excellence

Our employees receive the highest level of training and endeavor to be the best and the brightest in the medical device industry.

We are pleased to offer a comprehensive benefit plan that supports the overall health and wellness needs of our employees and their families.

Job Summary

Liaison with Regulators and in-country Regulatory Partners to develop and implement country specific regulatory strategies to achieve business objectives. Provides leadership for product registration and quality and regulatory compliance initiatives globally.

Essential Duties and Responsibilities

Qualifications

The requirements listed below are representative of the knowledge, skill or ability required.

Education and Experience

Bachelors Level of Degree in the similar field of study.

15+ years of demonstrated experience in Regulatory Affairs medical industry, 7+ years management experience leading a team

Advanced degree preferred, Professional regulatory certification(s) preferred

Skills / Knowledge

Demonstrated experience achieving regulatory approvals

Demonstrated ability to manage FDA and third party audits

Extensive background in the development of regulatory submissions and documentation.

Demonstrated experience managing quality system activities.

Excellent grasp of change control and test / validation requirements.

Strong strategic, decision making, and risk assessment abilities.

Highly developed written and oral communication, presentation, technical writing and editing skills.

Excellent organizational, leadership, and interpersonal skills.

Thorough knowledge of product development process and design control.

Knowledge of EU MDD, CMDR, PMDA / PAL, APAC Country requirements, LATAM

Proficient in the following computer software applications : Microsoft Office

Exceptional interpersonal skills.

Strong organizational skills.

Strong communication skills (written and verbal). Ability to effectively communication both internally and externally.

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence.