Regulatory Affairs Specialist jobs in Medford, OR
Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Specialist jobs
Principal Regulatory Affairs Specialist- USA Remote
- AngioDynamics
-
Myrtle Point, OR
FULL_TIME
-
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
We are pleased to offer a comprehensive benefit plan that supports the overall health and wellness needs of our employees and their families.
Performs full-range of regulatory functions required for Global product registrations, new product development, and internal documentation review for assigned strategic business units serving as the Regulatory Affairs resource. This role manages assigned regulatory programs working towards successful approval and/or clearance of new and/or revised products.
Essential Duties and Responsibilities- Provides Regulatory Affairs guidance throughout the product development cycle, and coordinating team inputs for submissions.
- Functions as Regional Regulatory Affairs Project Manager. Prepare reports including the priority list of projects, status and estimated completion dates as required.
- Prepares and reviews submissions for global regulatory applications as well as internal regulatory file documentation.
- Advise on requirements for FDA registration and CE mark and support preparation of the Technical File, when required.
- Conducts review of device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.
- Keeps AngioDynamics management informed of new and revised international regulatory requirements.
- Maintain AngioDynamics’ regulatory files.
- Manage Regional internal audits, customer audits, and third-party audits, including those Regional regulatory agencies, and US as necessary, and serves as a Deputy Liaison for certain regulatory inspections when required.
- May direct and coordinate activities of less senior Regulatory Affairs staff, including coaching, mentoring, advising and providing feedback.
- Provides technical guidance to team during the course of submission preparation and interaction with regulatory bodies.
- Reviews and edits submissions prepared by team members.
- Supports and maintains Quality initiatives in accordance with the Quality Policy.
- Provides Regulatory Affairs training/mentoring to other employees.
- Implements regulatory strategies for new and modified products.
- Reviews and assesses product and manufacturing changes for compliance with applicable regulations.
- Conducts regulatory due diligence for potential partners/products.
- Prepares Field Action reports to fulfill global regulatory requirements.
- May perform other duties as assigned.
- Bachelor’s Level of Degree in the scientific or technical discipline field of study.
- 10-12 years of demonstrated experience in Regulatory Affairs. Medical industry experience preferred.
- No Certifications Required.
- Any preferred education, experience or certifications: RAC Certification or equivalent preferred but not essential.
- Knowledge of 21 CFR/GMP/ISO 13485 series regulations and guidance.
- Demonstrated experience in the successful preparation, submission and prosecution of regulatory submissions, including 510(k), IDE and Technical Files for US and international registrations. Experience supporting international clinical studies would be an advantage.
- Demonstrated ability to manage Notified Body, FDA and other third-party audits.
- Exceptional interpersonal skills.
- Excellent written and oral communication skills.
- Excellent organizational skills.
- Working knowledge of Microsoft Office.
- Knowledge of medical product development and design control.
- Fluent in English (both 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.
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.
- frequently
- occasionally
- Ability to regularly sit or stand for extended periods of time.
- This position requires some travel up to 10% 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 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. - 17 Days Ago
Principal Regulatory Affairs Specialist- USA Remote
- AngioDynamics
-
Remote, OR
FULL_TIME
- Performs full-range of regulatory functions required for Global product registrations, new product development, and internal documentation review for assigned strategic business units serving as the R...
- 12 Days Ago
Public Affairs Assistant (OA)
- US Veterans Health Administration
-
White, OR
FULL_TIME
- Duties ***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION*** Major duties and responsibilities include: Performs public...
- 18 Days Ago
Public Affairs Assistant (Office Automation)
- US Veterans Health Administration
-
White, OR
FULL_TIME
- Duties ***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION*** Major duties and responsibilities include: Performs public...
- 4 Days Ago
Covid System Administrator - US Department of Veteran Affairs
- TLN Worldwide Enterprises Inc
-
White, OR
FULL_TIME
- DescriptionPosition Title: COVID Systems AdministratorAs an onsite Systems Administrator on our project, you will be supporting the Department of Veterans' Affairs. You'll analyze problem areas and op...
- 4 Days Ago
Record specialist
- Britt Music & Arts Festival
-
Medford, OR
FULL_TIME
- Are you interested in criminal justice and law enforcement?Are you looking for a career that will make a difference in your community? Do you enjoy a workplace where every day is a little different fr...
- 18 Days Ago
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0 Regulatory Affairs Specialist jobs found in Medford, OR area
Mobile Phlebotomist
- Premise Health Systems
-
Medford, OR
- eHealthScreenings, a Premise Health Company that specializes in national biometric screenings, has exciting opportunitie...
- 4/26/2024 12:00:00 AM
Legal Admin Specialist (Estate & Gift Tax) (Estate Tax Technical Advisor) (TEMP NTE 1 YR MBE, MBP)
- Department Of The Treasury
-
Medford, OR
- Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED (SBSE)DIVISION? A description of the business units can be found at: htt...
- 4/26/2024 12:00:00 AM
Transportation Engineer - Entry Level
- Dowl, Llc
-
Medford, OR
- ** Transportation Engineer - Entry Level** **Job Category****:** Engineering **Requisition Number****:** TRANS001730 Sho...
- 4/26/2024 12:00:00 AM
Transportation Engineer - Mid Level
- Dowl, Llc
-
Medford, OR
- ** Transportation Engineer - Mid Level** **Job Category****:** Engineering **Requisition Number****:** TRANS001733 Showi...
- 4/26/2024 12:00:00 AM
8257 - Community Health Nurse I (Health & Human Services)
- Jackson County, OR
-
Medford, OR
- Salary: $33.10 - $44.27 Hourly Location : Medford, OR Job Type: Full Time Job Number: 8257 Department: Health and Human ...
- 4/25/2024 12:00:00 AM
8298 - Part-Time Community Health Nurse I (Health & Human Services)
- Jackson County, OR
-
Medford, OR
- Salary: $33.10 - $44.27 Hourly Location : Medford, OR Job Type: Part-Time Job Number: 8298 Department: Health and Human ...
- 4/25/2024 12:00:00 AM
Product Development Manager
- Harry & David
-
Medford, OR
- THIS ROLE IS ONSITE AND LOCATED IN BEAUTIFUL SOUTHERN OREGON!!!! At Harry & David we Grow together, Learn together, and ...
- 4/25/2024 12:00:00 AM
8421 - Legal Assistant I (District Attorney)
- Jackson County, OR
-
Medford, OR
- Salary: $17.86 - $23.88 Hourly Location : Medford, OR Job Type: Full Time Job Number: 8421 Department: District Attorney...
- 4/22/2024 12:00:00 AM
About Medford, Oregon
Medford is located approximately 27 miles (43 km) north of the northern California border at 42.3°N. According to the United States Census Bureau, the city has a total area of 25.74 square miles (66.67 km2), of which, 25.73 square miles (66.64 km2) is land and 0.01 square miles (0.03 km2) is water. The Pacific Ocean is about 75 miles (121 km) west of the city, and is the nearest coast. The nearest river is the Rogue River (8 mi or 13 km), and the nearest lake is Agate Lake (13 mi or 21 km).
Nearby cities include Grants Pass, Klamath Falls, Ashland, Roseburg, Redding (California), and Crescent ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$75,726 to $101,485
Medford, Oregon area prices
were up 2.5% from a year ago
were up 2.5% from a year ago
What does a Regulatory Affairs Specialist do?
Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020