Regulatory Relations Specialist jobs in Lake Oswego, 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...
- Just Posted
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...
- 17 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...
- 9 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 Lake Oswego, OR area
ID 5906 - Temporary Educational Assistant - General - 6.5 hours/day for 186 days
- Lake Oswego School District
-
Lake Oswego, OR
- Position Type: Support Staff/Educational Assistant Date Posted: 4/19/2024 Location: River Grove Elementary School Date A...
- 4/25/2024 12:00:00 AM
Financial Analyst/Underwriter - Construction Surety
- The Travelers Indemnity Company
-
Lake Oswego, OR
- Who Are We? Taking care of our customers, our communities and each other. That's the Travelers Promise. By honoring this...
- 4/24/2024 12:00:00 AM
Field Mechanic III
- Hiring Now!
-
Lake Oswego, 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
Executive Director - Oswego Place by Bonaventure
- Bonaventure Senior Living
-
Lake Oswego, OR
- Oswego Place by Bonaventure has an exciting job opening for an Executive Director! Salary From $85,000 The Executive Dir...
- 4/24/2024 12:00:00 AM
Electrical Engineer, PE
- Barry-Wehmiller
-
Lake Oswego, OR
- About Us Design Group operates from more than 45 offices in the United States and India, providing engineering, consulti...
- 4/24/2024 12:00:00 AM
Grocery Clerk
- New Seasons Market, LLC
-
Lake Oswego, OR
- ** Position Description** **Grocery Clerk** Location **Mountain Park** City **Lake Oswego, OR** Starting Pay **$16.25 - ...
- 4/24/2024 12:00:00 AM
Store Support Supervisor (Customer Service, Front End Support)
- Whole Foods Market Inc.
-
Lake Oswego, OR
- **NYC CANDIDATES:** As mandated by New York City any New Member hired or Team Member transferring into NYC locations mus...
- 4/23/2024 12:00:00 AM
Mortgage Retail Sales Associate Manager (SAFE)
- Wells Fargo & Co.
-
Lake Oswego, OR
- **Mortgage Retail Sales Associate Manager (SAFE)** Location: Lake Oswego, Oregon **Job ID** R-137295 At Wells Fargo, we ...
- 4/23/2024 12:00:00 AM
About Lake Oswego, Oregon
According to the United States Census Bureau, the city has a total area of 11.35 square miles (29.40 km2), of which, 10.68 square miles (27.66 km2) is land and 0.67 square miles (1.74 km2) is water. That area does not include the more than 1,100 acres (4.5 km2) of unincorporated land within the urban services boundary as defined by Clackamas County.
Oswego Lake is a lake, originally named Waluga (wild swan) by Clackamas Indians which has been expanded is and currently managed by the Lake Oswego Corporation. The lake supports watercraft, and a dock floats at the lake's east end where boaters ca...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Relations Specialist jobs
$77,348 to $106,185
Lake Oswego, 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