Vice President, Regulatory Affairs (Hybrid) - AngioDynamics : Job Details

Vice President, Regulatory Affairs (Hybrid)

Marlborough, MA, USA

Job Description

Posted Monday, August 11, 2025 at 4:00 AM

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 To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

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

• Responsible for post-market surveillance, regulatory and quality compliance, as well as global regulatory affairs.
• Provide technical guidance and support for development of Regulatory submissions consistent with country-specific requirements
• Collaborate with Regulatory Franchise Directors to Develop Regulatory strategies for existing and new products registrations.
• Collaborate with International Sales and Marketing.
• Direct and coordinate resources related to global submission activities.
• Ensures that effective regulatory strategies are developed and implemented for new and modified devices to assure timely approval/market clearance/registrations, in support of corporate goals and objectives.
• Assures consistency and quality of submissions, through technical guidance to team during the course of strategy formulation and submission preparation.
• Establish project priorities to meet business objectives.
• Support and maintain Quality initiatives in accordance with Quality Policy.
• Continuously assess ways to improve Quality.
• Advise team of prevailing and evolving global regulatory requirements and environment.
• Develop, implement, and maintain policies and procedures.
• Coordinate post-market approval activities.
• Participate in trade and professional organizations.
• Provide training to manufacturing and development teams on key global technical documentation / data requirements.
• Manage in order to ensure compliance with all relevant regulatory/legal requirements.
• Establish project priorities to meet business objectives, develop and report metrics.
• Ability to travel domestically and internationally as business requires.
• May perform other duties as assigned

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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other legally protected status.The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.AngioDynamics does not accept resumes or candidate submissions from third-party recruiters and/or vendors who are not expressly under current written contract.Your ultimate salary may vary depending on your job-related skills, knowledge, and experience.