Regulatory Relations Specialist jobs in Oregon City, OR
Regulatory Relations Specialist files applications and interacts with governmental officials during the regulation and certification process for a plant or other facility. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Relations Specialist gathers data pertaining to organizational projects and their impact on the regulation process. May require a bachelor's degree. Additionally, Regulatory Relations Specialist typically reports to a supervisor or manager. To be a Regulatory Relations Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (Copyright 2024 Salary.com)
Recently Added Regulatory Relations Specialist jobs
Regulatory Specialist
- A-dec, Inc. (USA)
-
Newberg, OR
FULL_TIME
- At A-dec, we do more than create the highest quality products and services for the dental industry; we strive to deliver a superior employment experience for each of our team members. With an environment that encourages and assists each person in developing to their highest potential, a career at A-dec is incredibly rewarding. Overview This position is responsible for the coordination, compilation and maintenance of various compliance activities and records to ensure A-dec products and systems are in compliance with applicable federal and international quality and regulatory requirements. The position provides support for the Quality/Regulatory department and partners across business functions to ensure efficient, compliant business processes and environment. Duties and Responsibilities: Identify requirements for new or revised quality system procedures and provide direction for the preparation and control of these documents. Help create, develop, and maintain procedures/records to support compliance with applicable quality/regulatory requirements company wide. Represent regulatory on various cross-functional teams to ensure compliance with requirements and procedures. Partner with teams, execute tasks, and ensure timely compilation of documents/records. Prepare, organize, and coordinate content to ensure compliance for product submissions to the FDA, Health Canada, EU, or other regulatory agencies. Prepare and maintain listings and registrations of medical devices and/or establishments with regulatory agencies. Manage the internal audit process, lead audit teams, and/or act as lead auditor to conduct ongoing internal audits in all areas of the company to ensure quality systems are functioning effectively in conformance to regulatory requirements. Guide and provide assistance to external auditors during official audits. Analyze audit results and provide direction for necessary corrective action related to process issues and continuously improve internal audit methods to ensure A-dec quality system standards are maintained. Gather, prepare and verify timely financial information for Sunshine Act reporting. Submit accurate information to appropriate regulatory agencies. Research and review information from external sources to stay abreast of regulatory and technical developments in the industry. Evaluate impact to A-dec in order to achieve and maintain regulatory compliance. Conduct regulatory reviews of customer complaints; assess and record the regulatory reportability decision. Assist in developing and delivering regulatory training for company employees on a wide variety of regulatory topics. Provide supplemental required training for internal auditors and coordinate professional training as a requisite for new auditors, as needed. Perform other duties as required. Minimum Qualifications: Minimum 2-4 years of experience in Regulatory Affairs. Demonstrated working knowledge of federal/international medical device regulations, guidance, and standards (e.g., FDA, CMDR, MDD/MDR, ISO 13485, MDSAP) applicable to A-dec products. Ability to read, understand and interpret complex laws, standards, rules, and regulations. Ability to work under minimal supervision and with all levels of the organization. Must have strong planning and organizational skills with the ability to prioritize work and manage time effectively in both a team environment and as an individual contributor. Must also show attention to detail and have the ability to concurrently work with multiple deadlines while remaining results oriented. Must have excellent verbal and written communications skills. Strong PC skills required, using general office software and database systems. Occasional travel may be required. Preferred Qualifications: Bachelor’s degree in Biology, Chemistry, Engineering, or Regulatory Affairs with experience working with the FDA, global regulatory agencies or equivalent. Experience in the medical device industry and/or regulatory science industry. Experience following regulatory document and GMP requirements. At A-dec, we value our people and show it by prioritizing an inclusive culture, total well-being, and opportunities for learning and career advancement. A background check and screen for the illegal use of drugs is required. A-dec is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. In addition, A-dec will not discriminate against applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another. *VEVRAA Federal Contractor” A-dec is interested in qualified candidates authorized to work in the United States for US-based positions. We are unable to sponsor or take over sponsorship of employment visas. What's your next thing? You are a dreamer. A doer. The one who never stops seeking a better way. You are the kind of person we are looking for to join our team. If you know A-dec, you know that we are a global, family-run company with a big name in the dental industry. But we didn’t get here by settling for the status quo. We are perpetually pursuing ways to improve our products and consequently, the lives and well-being of our doctors and patients. A-dec encourages collaboration, believing that curiosity leads to innovation, and diversity and cross-function create the unexpected. We work hard. We play hard. And we never forget that the time you balance outside of work shapes and defines you as a person. Let's make a difference together.
- 12 Days Ago
Compliance Regulatory Operations Specialist
- Nectar Markets
-
Portland, OR
FULL_TIME
- Compliance/ Regulatory Operations Technician - Partially remote/Partial In-Office at our Warehouse. Who we are:The Nectar family is a diverse group of hard-working and talented individuals, who are br...
- 2 Days Ago
Provider Relations Specialist Lead
- CareOregon
-
Portland, OR
FULL_TIME
- Career Opportunities: Provider Relations Specialist Lead (24293) Requisition ID 24293 - Posted 05/23/2024 - CareOregon - Full Time - Permanent - Portland - Multi Location (9) Job Description Print Pre...
- Just Posted
Provider Relations Specialist II
- CorVel Brand
-
Portland, OR
FULL_TIME
- Assists providers via phone and email with basic to complex bill review questions and requests. Documents bill review errors for tracking and trending to improve team error rate. Acts as a positive an...
- 5 Days Ago
Provider Relations Specialist II
- CorVel Corporation
-
Portland, OR
FULL_TIME
- Assists providers via phone and email with basic to complex bill review questions and requests. Documents bill review errors for tracking and trending to improve team error rate. Acts as a positive an...
- 5 Days Ago
Provider Relations Specialist II
- CareOregon
-
Portland, OR
FULL_TIME
- Career Opportunities: Provider Relations Specialist II (24285) Requisition ID 24285 - Posted 05/14/2024 - CareOregon - Full Time - Permanent - Portland - Multi Location (2) Job Title Provider Relation...
- 6 Days Ago
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0 Regulatory Relations Specialist jobs found in Oregon City, OR area
UK Investment Counsellor (Financial Advisor Alternative)
- Fisher Investments
-
West Linn, OR
- Stop prospecting! Come join our firm as an Investment Counsellor for a provided roster of high-net-worth clients. Since ...
- 5/24/2024 12:00:00 AM
Medical Coder
- TalentPlug LLC
-
Clackamas, OR
- ***No C2C*** ***Only W2*** Remote working after on-site training (2-4 weeks) Job Summary: This is an experienced coding ...
- 5/24/2024 12:00:00 AM
Nursing Professional Development Consultant - ER
- Comprehensive Staffing Solutions of Georgia
-
Clackamas, OR
- Job Description The Nursing Professional Development Consultant is a registered nurse with expertise in nursing educatio...
- 5/24/2024 12:00:00 AM
Patient Access Representative I
- Kaiser Permanente
-
Clackamas, OR
- Description: Job Summary: The Patient Access Representative I is a unique role within the Kaiser Permanente Health Syste...
- 5/24/2024 12:00:00 AM
Senior IRP Program/Regulatory Specialist - Portland, Oregon - #112155
- PacifiCorp
-
Portland, OR
- Join Our Team! PacifiCorp is seeking customer-centric candidates to grow and sustain our commitment to a culture of cust...
- 5/23/2024 12:00:00 AM
Nurse Manager
- Monte Nido & Affiliates, LLC
-
West Linn, OR
- We save lives while providing the opportunity for people to realize their healthy selves.: Nurse Manager Monte Nido Port...
- 5/21/2024 12:00:00 AM
Field Mechanic III
- Hiring Now!
-
Gladstone, OR
- About the Role: The Sr. Field Mechanic with MYR Group you'll travel to project sites across the designated service area,...
- 5/21/2024 12:00:00 AM
Field Mechanic III
- Hiring Now!
-
West Linn, OR
- About the Role: The Sr. Field Mechanic with MYR Group you'll travel to project sites across the designated service area,...
- 5/21/2024 12:00:00 AM
About Oregon City, Oregon
The town is divided into upper and lower areas. The lower area is on a bench next to the Willamette River. The upper area is atop a bluff composed of Canemah basalt, which flowed about 2.5 million years ago from a vent 7.5 miles (12 km) to the southeast in the Boring Lava Field. For many years, Indian trails connected the two levels, but stairs were built in the 19th century. In 1915 the town built the water-powered Oregon City Municipal Elevator to connect the two parts, which was converted to electricity in the 1920s. In 1952, a new electric elevator was constructed with the specification th...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Relations Specialist jobs
$77,051 to $105,777
Oregon City, Oregon area prices
were up 3.9% from a year ago
were up 3.9% from a year ago
What does a Regulatory Relations Specialist do?
Regulatory Relations Specialist in Albany, GA
The Regulatory Relations Specialist is responsible for the execution of the overall strategy for regulatory engagement and enterprise-wide standards. This includes assisting with the management of regulatory examinations, inquiries and meetings. Additional responsibilities include.
December 09, 2019
Regulatory Relations Specialist in Monroe, LA
We are looking for a Marketing Specialist to plan, coordinate and manage marketing campaigns and activities across marketing channels.
February 06, 2020