Regulatory Affairs Specialist--Temporary 12 Months (Remote)
AngioDynamics

Job Info

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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

Responsible for determining the path to market for new and modifications to existing products in compliance with Regulations of intended market territory and for guiding teams on the required deliverables to support the Regulatory status of products distributed by AngioDynamics Inc.

Essential Duties and Responsibilities

• Under minimal supervision, acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.

• Assist with developing and implementing regulatory strategies for new and modified medical devices.
• Research and prepare recommendations on pathway for a new device, proposed device change or modification to support International Registrations.
• Apply scientific/technical knowledge to guide and strengthen development of regulatory submissions.
• Compile necessary information and prepare Regulatory license applications that meet specific country requirements to support international markets, as well as internal regulatory file documentation
• Prepare and maintain Technical Documentation Files (EU Tech Files and Design Dossiers; and IC Dossiers)
• Review device labeling and advertising materials for compliance with regulatory product approvals (submissions/licenses) and applicable country regulations; analyze and recommend appropriate changes.
• Review and recommend action on product and manufacturing changes in compliance with applicable regulations.
• May act as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
• Prepare Export Certificates (CFGs, CFS, etc.)- apply knowledge of specific country requirements to obtain approvals from USA regulatory agencies and International embassies
• Prepare product and establishment registration/listing with International Regulators primarily for the EU and APAC.
• Collaborate with internal (Quality/Ops/R&D) and external (Partners/Distributors) groups to obtain documentation necessary to develop required Field Action reports to Regulators (e.g., FDA, CA, EU) including Initial, Interim and Close-out Report
• Liaison with global Regulatory partners.
• Contribute as a team member on projects sustaining the regulatory and quality compliance of products and the continued enhancement of the organization
• Support and maintain Quality initiatives in accordance with the Quality Policy.
• Continuously assess ways to improve Quality.
• This position has potential for travel to domestic and international facilities and meetings.
• May perform other duties as assigned

Regulatory Responsibilities

• Manages in order to ensure compliance with all relevant regulatory/legal requirements.

Quality Systems Duties and Responsibilities

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements

Education and Experience

• Bachelors Level of Degree in a scientific or technical discipline field of study
• Equivalent work related experience acceptable in lieu of degree
• 1-2+years of experience in Regulatory Affairs supporting EU MDR/International registrations.
• Medical industry experience required.

Skills/Knowledge

• Experience in the following computer software applications: Microsoft Office
• General understanding of product development process and design control.
• Effective written and oral communication, technical writing and editing skills.
• Effective research and analytical skills.
• Ability to work independently with minimal supervision.
• Working knowledge of FDA and international regulations.
• Ability to manage several projects simultaneously
• Exceptional interpersonal skills.
• Strong organizational skills.
• Strong communication skills (written and verbal).
• Ability to effectively communicate 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.

Physical/Work Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job:

§ Work safely and follow all OSHA regulations and company safety policies and procedures.

§ For all on-the-job injuries or accidents, must notify manager/supervisor immediately.

§ Exposure to standard office environment

§ Ability to frequently lift and/or move up to 15 lbs

§ Ability to occasionally lift and/or move up to 50lbs

§ Ability to regularly sit or stand for extended periods of time

• This position requires some travel up to 5% of the time

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.

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