AngioDynamics Regulatory Affairs Specialist I in Marlborough, Massachusetts
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 products.
- 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 (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 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.
- Develop and maintain products listing/establishment details required to prepare documentation for product importation into USA and into International sites.
- 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 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
- 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.
- May perform other organization projects as assigned by supervisor
Education & Experience
- Bachelor’s degree in a scientific or technical discipline.
- 1-5 Regulatory Affairs experience or equivalent knowledge.
- 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.
- Medical industry experience preferred.
- Ability to manage several projects simultaneously
- Proficiency with Microsoft Office.
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.
- 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.
As an Equal Opportunity / Affirmative Action Employer, AngioDynamics will not discriminate in its employment practices due to an applicant’s race, color, creed, religion, sex (including pregnancy, childbirth or related medical conditions), sexual orientation, gender identity or expression, age, national origin, marital status, citizenship, physical and mental disability, criminal record, genetic information, predisposition or carrier status, status with respect to receiving public assistance, domestic violence victim status, a disabled, special, recently separated, active duty wartime, campaign badge, Armed Forces service medal veteran, or any other characteristics protected under applicable law.
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.
Requisition Number: 1500BR
Title: Regulatory Affairs Specialist I
Type of Position: Fulltime-Regular
Location: Marlborough, MA