Regulatory Affairs Specialist ll
JOB SUMMARY – To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Responsible for determining the path to market for new and modifications to existing products in compliance with Regulations of intended market territory and for independently 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.
▪ Leads in the development and implementation of Regulatory strategies for new and modified medical devices.
▪ Researches and prepares recommendations on pathway for a new device, proposed device change or modification, independently (e.g. 510(k), PMA, Design Dossier, Shonin, Canadian License).
▪ 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 and approve device labeling and advertising materials for compliance with Regulatory product approvals (submissions/licenses) as well as applicable country regulations; analyze, recommend, and assure implementation of 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, independently providing Regulatory Affairs feedback and guidance throughout the product development cycle.
▪ Develop and maintain product listing/establishment details required to prepare documentation for product importation into USA and into International sites.
▪ Prepare Export Certificates (CFGs, CFS, etc.)– must have and apply knowledge of specific country requirements to lead in obtaining approvals from USA regulatory agencies and International embassies.
▪ Prepare product and establishment registration/listing with Regulators (e.g., USA (FDA, Customs), Europe (AR, NB, CA), Australia, Health Canada).
▪ 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.
▪ Primary contact with global Regulatory partners.
▪ Lead regulatory projects as required.
▪ Contribute and lead 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 and support implementation of ways to improve Quality.
▪ This position has potential for travel to domestic and international facilities and meetings.
▪ May perform other duties as assigned
Supervisory Responsibilities No
▪ 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
QUALIFICATIONS –The requirements listed below are representative of the knowledge, skill or ability required.
Education and Experience
▪ Bachelor's Level of Degree in the scientific or technical discipline field of study
▪ Equivalent work related experience acceptable in lieu of degree Yes No
▪ 4 years of demonstrated experience in Regulatory Affairs or equivalent knowledge.
▪ No Certifications Required
▪ Any preferred education, experience or certifications: Master's degree, Medical industry experience, and/or RAC Certification preferred.
▪ Experience in the following computer software applications: Microsoft Office
▪ In depth understanding of product development process and design control.
▪ Effective research and analytical skills.
▪ Ability to work independently with minimal supervision.
▪ Exceptional knowledge of FDA and international regulations.
▪ Ability to manage several projects simultaneously and independently.
▪ Exceptional interpersonal skills.
▪ Strong organizational skills.
▪ Effective written and oral communication, technical writing and editing skills.
▪ 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.
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 (insert any extreme climate and/or work conditions) standard office environment
▪ Ability to frequently lift and/or move up to 15lbs
▪ 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
By signing the Learning & Development training form, I understand that the company reserves the right to add to or revise an employee’s job duties at any time at its sole discretion. All requirements are subject to possible modification to reasonably accommodate individuals with disabilities. This document does not create a contract of employment between AngioDynamics and any individual, express or implied. All employees are, and remain, employees-at-will.
- Job Family 2.0 Administrative Professionals
- Job Function Regulatory
- Pay Type Salary
- Amsterdam, Netherlands