Regulatory Affairs Specialist jobs in Colorado
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
Senior Regulatory Affairs Specialist
- Eurofins Agroscience Services
-
Centennial, CO
FULL_TIME
-
Company Description
Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.
In 2018, Eurofins generated 4.2 billion Euro proforma turnover in 800 laboratories across 47 countries, employing about 45.000 staff.
Eurofins stands for a conception of clinical diagnostics entirely focused on excellence, innovation and technological investment. Eurofins clinical diagnostics offers testing services in all medical specialties.
As a central element in healthcare, clinical diagnostics contributes to every stage of patient care: predisposition, prevention, diagnostics, treatment monitoring and prognosis.
With hundreds of thousands of clinical diagnostics tests performed every day, the laboratories of the clinical diagnostics division strive to ensure that every patient, wherever he or she lives, has access to the most specialized and most innovative techniques for diagnosis, monitoring and therapeutic adjustment. Our logistics expertise and our daily sample collection and delivery network, guarantee perfect continuity in the provision of care while ensuring the same standard of quality and access to innovation across all the regions we serve.
Job Description
Senior Regulatory Affairs Specialist responsibilities include, but are not limited to, the following:
Under the direction of the Manager, Regulatory Affairs and Quality Assurance, this position in tandem with Senior Management, will assist with ensuring that DPT’s laboratories are compliant with the regulatory and accrediting organizations that oversee our laboratories.
This position works closely and collaboratively with other functional areas throughout the network of laboratories.- Evaluates the regulatory environment and contributes to providing internal advice on regulatory and accrediting compliance.
- Anticipates regulatory obstacles and emerging issues related to laboratory testing and the transplant industry/ community.
- Assists in the development of regulatory strategy and updates strategy based upon regulatory changes, as appropriate.
- Provides regulatory information and guidance to the regulatory groups and others within the organization.
- Identifies the need for new regulatory procedures, SOPs, and participates in development, training, and implementation of the regulatory processes.
- Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
- Assists other departments in the development of SOPs to ensure regulatory compliance, as needed.
- Provides regulatory input and technical guidance on applicable international regulatory requirements.
- Communicates and interacts with regulatory and/or accrediting authorities through appropriate communication tools.
- Works with cross-functional teams for interactions with regulatory authorities.
- Accountable for the organization, research, communication, maintenance, and growth of the DPT Regulatory Intelligence Library and addressing all regulatory inquiries in a timely manner.
- Maintains list of all applicable Standards and Regulations which apply to all DPT facilities.
- Maintains DPT regulatory licensing, certification and permits for all facilities including renewals, assay change notifications, site or lab director changes, etc. including updating and maintaining current regulatory status on websites (CAP.org, NYS HCS) and internal tracking spreadsheets (submissions, licenses/permits, etc.)
- Manages and maintains industry standards and guidance subscriptions, maintains relationships with industry organizations and communicates any output to stakeholders.
- Interprets and applies FDA and other industry regulations and standards to business practices and fit for purpose.
- Writes, edits, and maintains departmental standard operating procedures with management and team.
- Coordinates the internal Audit schedule and assign auditors as necessary to meet the scope and expectations of the schedule. Perform internal audits in auditor or lead auditor role.
- Organizes and compiles information for inspection/audit responses.
- Represents Eurofins DPT in lead or supporting role (e.g., host) for regulatory-based audits/inspections. Provide external auditors with requested information, ensure documentation is complete and accurate, and collaborate with operational staff for tours and interviews.
- Maintains and utilizes working knowledge of applicable regulations, standards and policies; keep current with all relevant federal, state and local regulations and standards.
- Performs duties and tasks in a timely and compliant manner, ensuring accurate documentation and conclusions.
Basic Minimum Educational Requirements:- Bachelor’s degree (Life Science preferred)
- Minimum 5-10 years of quality, laboratory and/or regulatory experience in a regulated industry.
- Minimum 5-7 years of experience with regulatory and/or accrediting agencies (i.e., FDA, ISO, ASHI, CMS-CLIA, etc.)
- Ability to work effectively under the expectations of the Quality Management System.
- Advanced analytical and problem solving skills.
- Computer skills in Word, Excel and other MicroSoft applications. Database management and/or development skills helpful but not required.
- Highly developed organizational and multitasking skills.
- Possess a high level of integrity (professional, diplomatic, confidential) with demonstrated interpersonal skills and the ability to positively interface with employees and management.
- High level skills in oral and written communications.
- Willing to travel to satellite locations for quality support, internal audits, and regulatory inspections, as applicable (≤20% travel).
- Quality Auditor Certification (ASQ or equivalent) desired.
- This laboratory carefully maintains all hazardous materials. All employees must abide by Eurofins DPT’s Safety and Exposure procedures. This includes using the provided safety clothing and equipment.
- For a list of potential chemical hazards, see the appropriate SDS sheet.
Position is full-time working full-time Monday - Friday 9:00am to 5:30pm, with overtime as needed. Candidates currently living within a commutable distance of Centennial, CO are encouraged to apply.- Compensation: $75,000 - $105,000
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer. - 5 Days Ago
Regulatory Affairs Specialist
- Highridge Medical
-
Westminster, CO
FULL_TIME
- Job Summary:HIGHRIDGE creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at HIGHRIDGE is not just work. Lif...
- 7 Days Ago
Senior Regulatory Affairs Specialist
- Eurofins
-
Centennial, CO
FULL_TIME
- Company DescriptionEurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes...
- 9 Days Ago
Regulatory Affairs Specialist
- Biodesix, Inc.
-
Louisville, CO
FULL_TIME
- ABOUT US: Biodesix is a leading diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics throug...
- 10 Days Ago
Regulatory Affairs Project Manager
- RapidAI
-
Golden, CO
FULL_TIME
- RapidAI is the global leader in using AI to combat life-threatening vascular and neurovascular conditions. RapidAI is empowering physicians to make faster decisions for better patient outcomes, leadin...
- 4 Days Ago
VP Government and Regulatory Affairs
- UCHealth
-
Aurora, CO
FULL_TIME
- The Opportunity Vice President, Government & Regulatory Affairs The Vice President Government & Regulatory Affairs develops, directs, executes, and manages UCHealth's strategic and day-to-day relation...
- 7 Days Ago
Regulatory Affairs Specialist jobs at Popular Companies
Regulatory Affairs Specialist
- GForce Life Sciences
-
Santa Clara, CA
- Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2 Job Summary We're looking for a Regulato...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- Alphatec Spine
-
Carlsbad, CA
- Primary responsibilities include the development of submissions for domestic and international clearances. Additionally,...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- Planet Pharma
-
- Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
- 6/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- Astrix
-
Fort Worth, TX
- Exciting 2 year development opportunity to work for a global leader dedicated to helping people see brilliantly. The lar...
- 6/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- Highridge Medical
-
Westminster, CO
- Job Summary: HIGHRIDGE creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation...
- 6/9/2024 12:00:00 AM
Regulatory Affairs Specialist
- CM Medical Recruitment
-
- CM Medical is seeking an experienced regulatory professional to join a fast growing team in the EP/CRM device space. In ...
- 6/8/2024 12:00:00 AM
Regulatory Affairs Specialist
- Baylor College of Medicine
-
Texas City, TX
- Division: Office of Research Work Arrangement: Onsite only Location: Texas Medical Center, Houston, TX Salary Range: $54...
- 6/8/2024 12:00:00 AM
Regulatory Affairs Specialist
- Net2Source Inc.
-
Palo Alto, CA
- Job Title: Regulatory Affairs Professional 4 Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hyb...
- 6/7/2024 12:00:00 AM
About Colorado
Colorado (/ˌkɒləˈrædoʊ, -ˈrɑːdoʊ/ (listen), other variants) is a state of the Western United States encompassing most of the southern Rocky Mountains as well as the northeastern portion of the Colorado Plateau and the western edge of the Great Plains. It is the 8th most extensive and 21st most populous U.S. state. The estimated population of Colorado was 5,695,564 on July 1, 2018, an increase of 13.25% since the 2010 United States Census.
The state was named for the Colorado River, which early Spanish explorers named the Río Colorado for the ruddy silt the river carried from the mountains. The...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$77,872 to $104,357
Most Popular Cities in Colorado 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