-
Senior Regulatory Affairs Specialist
5 days ago
Stryker Denver, United StatesWork Flexibility: Hybrid · We are currently seeking a · Senior Regulatory Affairs Specialist · to join our Sport Medicine business unit, part of the Stryker Endoscopy Division, to be based hybrid in Greenwood Village, CO. · Stryker is one of the world's leading medical techno ...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Stryker Denver, United StatesWork Flexibility: Hybrid · We are currently seeking a Senior Regulatory Affairs Specialist to join our Sport Medicine business unit, part of the Stryker Endoscopy Division, to be based hybrid in Greenwood Village, CO. · Stryker is one of the world's leading medical technology c ...
-
Senior Regulatory Affairs Specialist
1 week ago
Eurofins Agro Nl Denver, United StatesEurofins 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 ...
-
Regulatory Affairs Specialist
1 week ago
Highridge Medical Westminster, United StatesJob 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. Life at HIGHRIDGE is purpose-driven. Every day, you have the privilege of using ...
-
Public Affairs Specialist
2 weeks ago
U.S. Mint Denver, United States Full timeThe following are the duties of this position at the GS-9. If you are selected at a lower grade level, you will have the opportunity to learn to perform all these duties, and will receive training to help you grow in this position. · Participates in the planning, designing, devel ...
-
Regulatory Affairs Specialist
1 week ago
Highridge Medical Westminster, United StatesJob Summary: · HIGHRIDGE creates the worlds 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. Life at HIGHRIDGE is purpose-driven. Every day, you have the privilege of using ...
-
Senior Regulatory Affairs Specialist
6 days ago
Medtronic Boulder, United StatesSenior Regulatory Affairs Specialist – Acute Care & Monitoring · The Senior Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the United States and Europe. This positio ...
-
Student Affairs/Information Center Specialist
3 weeks ago
Front Range Community College Westminster, United StatesWho We AreWe are the largest community college in Colorado, enrolling close to 28,000 credit students annually in a diverse service area with broad cultural and recreational activities. We were one of 30 colleges in the initial American Association of Community Colleges Pathways ...
-
Public Affairs Specialist
4 weeks ago
U.S. Military Academy West Point, United States**Duties**: · - Oversee the content, design, and management of the U.S. Military Academy (USMA) installation web-page. · - Manage digital media content, themes, messages, and campaigns on the U.S. Military Academy (USMA) official social media platforms, such as, Facebook, Twitter ...
-
Senior Regulatory Affairs Specialist
6 days ago
EUROFINS VRL INC. Centennial, United StatesEUROFINS VRL INC. · Senior Regulatory Affairs Specialist · Centennial , · Colorado · Apply Now · Eurofins Scientific is an international life sciences company, whichprovides a unique range of analytical testing services to clients acrossmultiple industries. The Group believe ...
-
Senior Regulatory Affairs Specialist
1 week ago
Eurofins USA Clinical Diagnostics Centennial, United StatesJob Description · Job DescriptionCompany 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 ...
-
Senior Regulatory Affairs Specialist
16 hours ago
Medtronic Boulder, United StatesMedtronic · Senior Regulatory Affairs Specialist · Boulder , · Colorado · Apply Now · Senior Regulatory Affairs Specialist – Acute Care & Monitoring · The Senior Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities necessary to ...
-
Abbvie Denver, United StatesPetSmartColorado: Part Time Seasonal Associate in Highlands Ranch, COPetSmartColorado: Merchandising and Inventory Leader in Glendale, COPetSmartColorado: Pets Hotel Manager in Fort Collins, COPearsonSenior Software Developer in Boulder, COPetSmartColorado: Part Time Seasonal Ass ...
-
Chief Financial Officer
2 weeks ago
State of Colorado Denver, United StatesDepartment Information · This position is not part of the state-classified system. Applications will be considered from residents and non-residents of Colorado. · This posting has been extended through 6/2/2024 at 11:59pm. Applicants who have applied do not need to submit anoth ...
-
Accounts Payable Accountant
3 weeks ago
Jobot Denver, United StatesJob Description · Job DescriptionHybrid Remote + Amazing Benefits + Upward Mobility + Great People · This Jobot Job is hosted by: Ryan Kilroy · Are you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume. · Salary: $70,000 - $110,000 per year · A bi ...
-
Cytology Application Specialist
1 week ago
Hologic Denver, United StatesDiscover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day. · Our Cytology Applications teams are instrumental in providing the highest s ...
-
Vertiv Holdings, LLC Denver, United StatesThe Environmental Health and Safety Specialist will be responsible for supporting, coordinating, implementing and/or conducting environmental, safety, and health activities. Assisting to ensure employees are trained in environmental, safety, and health policies and procedures. Fa ...
-
Campus Safety Specialist
2 weeks ago
Red Rocks Community College Denver, United StatesSalary: $16.19 Hourly · Location : Lakewood, CO · Job Type: Part-Time · Job Number: SPEC · Division: Student Affairs · Opening Date: 06/03/2024 · Closing Date: 6/7/2024 4:59 PM Mountain · To Apply: Complete an application and attach the following: A cover letter describing ...
-
Compliance Specialist
3 weeks ago
Colorado Community College System Denver, United StatesSalary: $64, $75,000.00 Annually · Location : 9101 E Lowry Blvd Denver, CO · Job Type: Professional/Tech Full-time · Remote Employment: Flexible/Hybrid · Job Number: GJA NMC · Department: CCCS Finance & Administration · Division: CCCS Internal Audit · Opening Date: 05/22/2 ...
-
Marketing Director
2 weeks ago
Denver Health Denver, United StatesWe are recruiting for a Marketing Director to join our team · We are here for life's journey. · Where is your life journey taking you? · Being the heartbeat of Denver means our heart reflects something bigger than ourselves, something that connects us all: · Humanity in action, ...
Senior Regulatory Affairs Specialist - Denver, United States - Eurofins Agro NL
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
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 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 DescriptionSenior 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.
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 , 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.Qualifications
Basic Minimum Educational Requirements:
Basic Minimum Requirements
:
Minimum 5-10 years of quality, laboratory and/or regulatory experience in a regulated industry.
Minimum5-7 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.
Additional Information
Position is full-time working full-time
Monday - Friday9:
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
Please be aware that this role will require access to a site that requires COVID-19 vaccination or exemption from vaccination requirements.
Prior to starting work in this position, employees must show proof of full Covid-19 vaccination or exemption from vaccination requirements. Exemptions will be granted as warranted by medical contraindications, disability or sincerely held religious beliefs.
Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
#J-18808-Ljbffr