Regulatory Relations Specialist jobs in Clackamas, 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.
- 1 Month 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...
- 27 Days Ago
Labor Relations Specialist
- PacifiCorp
-
Portland, OR
FULL_TIME
- PacifiCorp is seeking customer-centric candidates to grow and sustain our commitment to a culture of customer service excellence, environmental sustainability and diversity, equity and inclusion. Gene...
- 16 Days Ago
Patron Relations Specialist
- Sunset Empire Park and Recreation District
-
Seaside, OR
PART_TIME
- Job Description Patron Relations Specialist GENERAL DESCRIPTION: The Patron Relations Specialist employed with the Sunset Empire Park and Recreation District is a customer service oriented individual ...
- Just Posted
Patient Relations Specialist
- Reflex Knee Specialists
-
Portland, OR
FULL_TIME
- Job description Work with the Dream Team at Reflex! Reflex is a specialty medical clinic providing non-surgical treatments for knee pain. We are seeking someone with exceptional interpersonal and comm...
- 8 Days Ago
Payor Relations Specialist
- RS Medical
-
Vancouver, WA
FULL_TIME
- Description RS Medical designs and builds prescription-grade medical devices that provide pain relief and muscle rehabilitation. Our DME products empower patients suffering from severe, often debilita...
- 1 Month Ago
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0 Regulatory Relations Specialist jobs found in Clackamas, OR area
Field Mechanic III
- Hiring Now!
-
Clackamas, OR
- About the Role: The Sr. Field Mechanic with MYR Group you'll travel to project sites across the designated service area,...
- 4/24/2024 12:00:00 AM
Human Resources Partner - Clackamas, OR
- VCA Animal Hospitals
-
Clackamas, OR
- The **Human Resources Partner (HRP),** located at one of our largest animal hospitals in the Portland, Oregon area, will...
- 4/23/2024 12:00:00 AM
Inpatient Facility Medical Coder (40h Day)
- Veracity Software Inc
-
Clackamas, OR
- Inpatient Facility Medical Coder (40h Day) Remote Clackamas, OR Candidates must reside either in Washington or Oregon to...
- 4/22/2024 12:00:00 AM
Cybersecurity Specialist
- Pyramid Consulting Inc
-
Clackamas, OR
- Immediate need for a talented Cybersecurity Specialist. This is a 06+ months Contract opportunity with long-term potenti...
- 4/22/2024 12:00:00 AM
Lead Dialysis Nurse - RN - Clinical Coordinator
- Fresenius Medical Care
-
Clackamas, OR
- PURPOSE AND SCOPE: Supports FMCNA's mission,vision, core values and customer service philosophy. Adheres to the FMCNA Co...
- 4/22/2024 12:00:00 AM
PHARMACY/CERTIFIED TECH
- Kroger
-
Clackamas, OR
- Job Description Provide exceptional customer service to help people live healthier lives by treating our customers/emplo...
- 4/21/2024 12:00:00 AM
Cybersecurity Specialist
- Pyramid Consulting, Inc
-
Clackamas, OR
- Immediate need for a talented Cybersecurity Specialist. This is a 06+ months Contract opportunity with long-term potenti...
- 4/20/2024 12:00:00 AM
Import Export Compliance
- Bridgewell Agribusiness
-
Clackamas, OR
- Job Description Job Description Basic Position Function Coordinate and manage flow of international and supply chain doc...
- 4/20/2024 12:00:00 AM
About Clackamas, Oregon
Clackamas is an unincorporated community and former census-designated place (CDP) in Clackamas County, Oregon, United States and is a suburb of Portland. The population was approximately seven thousand in 2010.
Clackamas is home to Camp Withycombe, which is a military base, and to a branch of the Kaiser Permanente Hospital.
Clackamas is part of the Portland Metropolitan Area and lies approximately 10 miles (16 km) southeast of downtown Portland and to the east of Interstate 205 along Oregon Routes 212 and 224 and to the north of the Clackamas River.
According to the United States Census Bureau...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Relations Specialist jobs
$77,199 to $105,981
Clackamas, 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