Regulatory Affairs Director jobs in Medford, OR

Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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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
    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.

    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.
    Education and Experience
    • 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.
    Skills/Knowledge
    • 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.
    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.
    • frequently
    • occasionally
    • Ability to regularly sit or stand for extended periods of time.
    • This position requires some travel up to 10% of the time
    EMPLOYEE ACKNOWLEDGMENT

    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.
  • 15 Days Ago

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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...
  • 10 Days Ago

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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...
  • 17 Days Ago

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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...
  • 2 Days Ago

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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...
  • 2 Days Ago

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Maintenance Director
  • trustwellliving-rogueriverplace
  • Klamath Falls, OR FULL_TIME
  • POSITION SUMMARY: Responsible for maintaining the community in the areas of physical plant, equipment, grounds, and for keeping accurate maintenance records. Responsible for following all regulations ...
  • 16 Days Ago

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0 Regulatory Affairs Director jobs found in Medford, OR area

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Director of Manufacturing
  • Noveske Rifleworks Llc
  • Grants Pass, OR
  • About the Company: Noveske Rifleworks is a renowned and highly respected name in the firearms industry, known for produc...
  • 4/25/2024 12:00:00 AM

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KFC General Manager
  • KFC
  • Medford, OR
  • At KFC, we feed the world. But we do more than fill people up. We fulfill their life. Our meals matter, and when we serv...
  • 4/24/2024 12:00:00 AM

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Technical Paid Director of Production Oregon Shakespeare Festival Ashland, OR US 04/18/2024
  • Playbill Inc.
  • Ashland, OR
  • 0 seconds of 3 minutes, 34 seconds Volume 0%Oregon Shakespeare FestivalAshland, ORUSCONTACT NAME DESCRIPTION The Directo...
  • 4/23/2024 12:00:00 AM

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MANAGER TRAINEE
  • AutoZone, Inc.
  • Medford, OR
  • The Manager in Training (MIT) position is expected to be a short-term transitional role that provides both work assignme...
  • 4/23/2024 12:00:00 AM

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Sales Key Holder
  • American Freight
  • Medford, OR
  • Job Type: Entry level; Full time Sales Manager Requirements: An Associate's degree, recent college graduate, and/or mili...
  • 4/22/2024 12:00:00 AM

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Management Trainee
  • Boise Cascade
  • Medford, OR
  • Many employers offer jobs; at Boise Cascade, we offer career opportunities. We are one of the largest manufacturers of p...
  • 4/22/2024 12:00:00 AM

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Director of Manufacturing
  • Noveske Rifleworks, LLC
  • Grants Pass, OR
  • About the Company: Noveske Rifleworks is a renowned and highly respected name in the firearms industry, known for produc...
  • 4/21/2024 12:00:00 AM

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Accounting Manager- Josephine County
  • Premier Community Supports
  • Grants Pass, OR
  • Job Type Full-time Description Premier Community Supports is now hiring an Accounting Manager! About Premier Premier Com...
  • 4/21/2024 12:00:00 AM

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 Director jobs
$168,519 to $240,010
Medford, Oregon area prices
were up 2.5% from a year ago

Regulatory Affairs Director in Spartanburg, SC
There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
December 13, 2019
Regulatory Affairs Director in New Brunswick, NJ
The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience.
February 12, 2020
Regulatory Affairs Director in Syracuse, NY
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
January 18, 2020