Regulatory Affairs Specialist jobs in Oregon
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. - 10 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...
- 5 Days Ago
Director Regulatory Affairs *Remote
- Providence Health
-
Beaverton, OR
FULL_TIME
- Description Providence Health Plan caregivers are not simply valued – they’re invaluable. Join our team and thrive in our culture of patient-focused, whole-person care built on understanding, commitme...
- 10 Days Ago
Director Regulatory Affairs *Remote
- Providence Health
-
Oregon, OR
FULL_TIME
- Description Providence Health Plan caregivers are not simply valued – they’re invaluable. Join our team and thrive in our culture of patient-focused, whole-person care built on understanding, commitme...
- 9 Days Ago
Director Regulatory Affairs *Remote
- Providence
-
Beaverton, OR
OTHER
- DescriptionProvidence Health Plan caregivers are not simply valued – they’re invaluable. Join our team and thrive in our culture of patient-focused, whole-person care built on understanding, commitmen...
- 9 Days Ago
Director Regulatory Affairs *Remote
- Providence
-
Portland, OR
FULL_TIME
- Description Providence Health Plan caregivers are not simply valued - they're invaluable. Join our team and thrive in our culture of patient-focused, whole-person care built on understanding, commitme...
- 21 Days Ago
Regulatory Affairs Specialist jobs at Popular Companies
Regulatory Affairs Specialist
- DivIHN Integration Inc
-
Green Oaks, IL
- DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, C...
- 4/19/2024 12:00:00 AM
Regulatory Affairs Specialist
- ProKatchers LLC
-
St Louis, MO
- Job Title: Regulatory Affairs Specialist Location: 63103, St Louis, Missouri, United States Duration: 24 Months Job Desc...
- 4/19/2024 12:00:00 AM
Regulatory Affairs Specialist
- Direct Recruiters, Inc.
-
Chicago, IL
- Our client is a global leader in ink and laser marking/coding industrial equipment manufacturing. They are seeking a Reg...
- 4/19/2024 12:00:00 AM
Regulatory Affairs Specialist
- Adecco Staffing, USA
-
San Diego, CA
- Regulatory Affairs Specialist Full Time San Diego, CA, US Salary Range: $90,000.00 To 110,000.00 Annually Monday - Frida...
- 4/19/2024 12:00:00 AM
Regulatory Affairs Specialist
- Coltene
-
Cuyahoga Falls, OH
- About the Organization Coltene is a global leader in the development, manufacture and sale of consumables and small-size...
- 4/19/2024 12:00:00 AM
Regulatory Affairs Specialist
- Morair Medtech, LLC
-
Seattle, WA
- Morair Medtech, LLC is at the forefront of medical technology, specializing in endobronchial treatments for lung disease...
- 4/18/2024 12:00:00 AM
Regulatory Affairs Specialist
- GForce Life Sciences
-
Lake Forest, IL
- Regulatory Affairs Specialist – Onsite in Lake Forest, IL Must be able to work W2 Summary Our client, a Fortune-500 Medi...
- 4/16/2024 12:00:00 AM
Regulatory Affairs Specialist
- Spectraforce
-
North Chicago, IL
- Job Title: Specialist Regulatory Affairs, Pacific Asia Location: North Chicago, IL 60064 Duration: 7+ Months Min pay rat...
- 4/15/2024 12:00:00 AM
About Oregon
Oregon (/ˈɒrɪɡən/ (listen) ORR-ih-gən) is a state in the Pacific Northwest region on the West Coast of the United States. The Columbia River delineates much of Oregon's northern boundary with Washington, while the Snake River delineates much of its eastern boundary with Idaho. The parallel 42° north delineates the southern boundary with California and Nevada. Oregon is one of only four states of the continental United States to have a coastline on the Pacific Ocean.
Oregon was inhabited by many indigenous tribes before Western traders, explorers, and settlers arrived. An autonomous government ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$77,169 to $103,419
Most Popular Cities in Oregon for Regulatory Affairs Specialist Jobs
What does a Regulatory Affairs Specialist do?
Regulatory Affairs Specialist in Petaluma, CA
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
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
Regulatory Affairs Specialist in Boulder, CO
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
February 03, 2020
Regulatory Affairs Specialist in Concord, NH
Are you working as a Regulatory Affairs Specialist? Help us rate Regulatory Affairs Specialist as a Career.
December 31, 2019