CrawlJobs Logo

Associate Regulatory Specialist II

edgertondental.co.uk Logo

Edgerton Dental Clinic

Location Icon

Location:
Poland , Kraków

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided

Job Description:

Ecolab is seeking to hire an Associate Regulatory Specialist II/Engineer located at our Krakow, Poland office. We are looking for the right candidate that has engineering experience. They will be responsible for ensuring our equipment complies with local regulatory requirements. They will work with cross-functional project teams to ensure compliance with our equipment and packaging. Their main duties will be organizing regulatory approvals for equipment (dispensers, controllers, wireless devices, pumps) in EU countries using local network support or laboratories/product certification services.

Job Responsibility:

  • Lead and coordinate efforts to ensure equipment satisfies appropriate testing standards mandatory for placing in the market
  • Obtain Drinking Water Directive and local Drinking Water Approvals
  • Create and maintain equipment technical files documenting equipment regulatory compliance meeting Machine Regulation requirements
  • Support Packaging & Packaging Waste Regulation (PPWR) by identifying requirements through building technical files
  • Define equipment in scope for WEEE and report of sales data to the authorities
  • Collect compliance documentation from suppliers (Reach, RoHS, EU DoC, Drinking Water)
  • Will work in close collaboration with larger EU Team to complete projects across all divisions
  • Organize laboratories and product certification agencies for testing equipment

Requirements:

  • Bachelor’s degree in electrical/Electronics/Industrial/Mechanical or Telecommunication Engineering
  • 2+ years of professional work experience working at a certification agency, testing lab or coordinating regulatory approvals
  • Able to clearly explain project status and hurdles
  • Experience in navigating cross functional teams to obtain results
  • Comfortable to perform administrative tasks like documentation collection, organizing files, and creating record documents
  • Project management experience
  • Familiar with extracting information from SAP, Excel, and Power Point
  • Used to work in virtual environment like Microsoft Teams and lead virtual meetings in English
  • Fluency in English

Nice to have:

  • 2+ years of experience working in a certification agency or testing lab or coordinating equipment regulatory approvals or related equipment compliance activity
  • Knowledge of European Regulations (Machinery, PPWR, ATEX, LVD, RoHS, WEEE, EMC)
  • Knowledge of telecommunications approvals (RED, FCC, type approval)
  • Strong interpersonal and networking skills
  • Savvy with knowledge management programs
  • Fluent in German language
What we offer:
  • Competitive Compensation: Attractive salary (Base pay & Variable Plan) and benefits package (private medical care, life insurance, stock purchase, lunch subsidy, sport cards)
  • Work-Life Balance: Flexible working arrangements with hybrid model of work (approx. 60% from the office and 40% from home)
  • Matrix Organization: Thrive in our matrix organization, working across Europe with various teams and cultural backgrounds
  • Collaborative Environment: Strong teamwork and diverse interactions
  • Development Opportunities: Personalized plans with rapid progression
  • Versatile Career Paths: Professional growth supported by active committee for different career levels
  • Supportive Culture: High employee satisfaction and responsive feedback
  • Learning and Innovation: Continuous learning and technical training incl. subject matter experts’ trainings, soft skills and management trainings and LinkedIn learning
  • Relocation Support: Assistance for international candidates and candidates living outside of Krakow
  • Social events such as family events and charity auctions
  • Comfortable working environment (Library, relaxation area, casual dress code)
  • Parking space for cars and bikes

Additional Information:

Job Posted:
May 05, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Associate Regulatory Specialist II

Office Support Specialist II

To provide fair and consistent regulation of insurance producers, adjusters, and...
Location
Location
United States , Cheyenne
Salary
Salary:
22.63 - 24.74 USD / Hour
dot.state.wy.us Logo
Wyoming Department of Transportation
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Associate's Degree (typically in Business)
  • 0-2 years of progressive work experience (typically in Business Office Communications) with acquired knowledge at the level of an Office Support Specialist I
  • OR 2-4 years of progressive work experience (typically in Business Office Communications) with acquired knowledge at the level of an Office Support Specialist I
  • Basic knowledge of computer applications, including Google suite and internet browsers
  • Ability to communicate clearly and professionally in writing and verbally
  • Knowledge of state laws and regulations governing insurance licensing
  • Knowledge of Department policies and practices relative to the licensing of individuals and firms
  • Knowledge of continuing education requirements
  • Knowledge of insurance industry terms, general practices, and procedures
  • Ability to prioritize assigned work and multi-task under pressure with constant interruptions
Job Responsibility
Job Responsibility
  • Review and analyze insurance license applications for individuals and corporations through interpretation of insurance statutes, regulations, and Department guidelines to determine eligibility for licensure
  • Process eligible applications and enter all necessary information into the Department database
  • Compose and relay correspondence relating to licensing
  • Process appointments, terminations, letters of clearance, and other miscellaneous licensing requests
  • Review and process renewal applications and required attachments and disclosures for continued eligibility for licensing, rejecting those that do not meet the required standards
  • Review continuing education provider and course applicants and renewals submitted for approval
  • Assist licensees regarding continuing education compliance
  • Extensive email, telephone, and in-person contact with applicants, licensees, insurance companies, state agencies, and other regulatory departments to provide information on licensing forms, procedures, testing, and education requirements pursuant to state laws and regulations
  • Participate in licensing team meetings and projects
  • Act as a resource to provide information or interpretation of specific rules/regulations to Department staff, members of the public, or other government entities
What we offer
What we offer
  • Comprehensive health, dental, and vision insurance
  • Paid vacation, sick leave, FMLA, and holidays
  • Retirement - Pension and 457B plans
  • Fulltime
Read More
Arrow Right
New

Appeals and Grievances Nurse Specialist RN II

The Appeals and Grievances (A&G) Nurse Specialist Registered Nurse (RN) II provi...
Location
Location
United States , Los Angeles
Salary
Salary:
88854.00 - 142166.00 USD / Year
lacare.org Logo
L.A. Care Health Plan
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Associate's Degree in Nursing
  • At least 5 years of experience in Clinical RN
  • At least 2 years in Medicare/ Medicaid in a managed care/ health plan environment
  • Excellent interpersonal and communication skills
  • Computer literacy and adaptability to computer learning
  • Time management and priority setting skills
  • Must be organized and a team player
  • Able to work effectively with various internal departments/service areas, L.A. Care's plan partners, participating provider groups, and other external agencies
  • Good working knowledge of regulatory requirements/standards
  • Registered Nurse (RN) - Active, current and unrestricted California License
Job Responsibility
Job Responsibility
  • Provides direct assistance to members with health care access or benefit coordination issues, ensuring that clinical grievances, complaints and complex issues are investigated and resolved
  • Conducts intake/triage and appropriate classification of Clinical A&G, and Pharmacy requests
  • Investigation, and resolution of clinical member complaints (grievances/appeals) utilizing all regulatory requirements
  • Works with the external providers and Participating Physician Group's (PPG) representatives to obtain relevant medical records and communication documentation
  • Prepares resolved complaint files for Centers for Medicare and Medicaid Services (CMS), DMHC, and external review organization (QIO or IRE)
  • Investigation and preparation of State Fair Hearing cases as assigned
  • Conducts reviews and presents to physicians, provider disputes which would be based on medical necessity reviews
  • When necessary, outreaches to providers, vendors, hospitals, and members to request necessary information or to provide case status and/or next steps
  • Participates inter-rater reliability training and assessments
What we offer
What we offer
  • Paid Time Off (PTO)
  • Tuition Reimbursement
  • Retirement Plans
  • Medical, Dental and Vision
  • Wellness Program
  • Volunteer Time Off (VTO)
  • Fulltime
Read More
Arrow Right

Quality Management Nurse Specialist RN II

The Quality Management Nurse Specialist RN II is responsible for overseeing the ...
Location
Location
United States , Los Angeles
Salary
Salary:
88854.00 - 142166.00 USD / Year
lacare.org Logo
L.A. Care Health Plan
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Associate's Degree in Nursing
  • At least 5 years of clinical experience as an RN in an acute hospital setting
  • Must have excellent written and verbal communication and presentation skills
  • Ability to manage projects independently and assume responsibility for successful completion
  • Ability to develop and maintain strong working relationships with internal and external clients/ customers /members
  • Must have excellent analytical skills, working knowledge of statistics and reporting
  • Must be detail-oriented and effective critical thinking skills
  • Proficient in Microsoft Office (Word, Excel)
  • Strong interpersonal skills and high level of professionalism
  • Ability to work independently and within a team environment
Job Responsibility
Job Responsibility
  • Overseeing the clinical aspects for quality improvement projects/activities
  • Ensuring program activities are completed in a high quality and timely manner and ensuring compliance with all regulatory guidelines
  • Leads and/or participates in multi-department/cross-functional committees and work groups which support key initiatives, prepares reports, data, agendas/minutes or other materials for committee presentation and management
  • Develops and implements project-related communication including, but not limited to, member/physician mailings, IVR scripts, emails, business plans, graphics, and maintains minutes and agendas
  • Develops and/or maintains relationships with other external organizations to expand key partnerships
  • Creates, maintains and implements training/education and supporting documentation for internal and external clients/customers/members
  • Develops and submits regulatory reports at the time and in the manner required by state or federal agencies such as Centers for Medicare and Medicaid Services(CMS)
  • Conducts/ performs clinical review of assigned potential quality issue cases (PQI), and close cases within regulatory timeframe, and presents appropriate cases to the peer review committee for action and resolution
  • Perform other duties as assigned
What we offer
What we offer
  • Paid Time Off (PTO)
  • Tuition Reimbursement
  • Retirement Plans
  • Medical, Dental and Vision
  • Wellness Program
  • Volunteer Time Off (VTO)
  • Fulltime
Read More
Arrow Right

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...
Location
Location
Turkey
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
  • Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
  • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
  • Global clinical trial experience
  • Must be fluent in English and in the native language(s) of the country they will work in
  • Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
  • Valid driver’s license and passport required
  • Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
  • Demonstrated knowledge of global and local regulatory requirements
  • Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
Job Responsibility
Job Responsibility
  • Oversight of Monitoring Responsibilities and Study Conduct
  • Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
  • Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
  • During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
  • Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
  • Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
  • provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
  • Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
  • Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
  • Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
What we offer
What we offer
  • Flexible work arrangements
  • Career growth and development
  • Supportive and inclusive environment
  • Diverse therapeutic areas and project exposure
  • Advanced Technology
Read More
Arrow Right

Sshe Specialist II

Safety, Security, Health, and Environment (SSHE) Specialists not only support on...
Location
Location
United States , Williston
Salary
Salary:
Not provided
airswift.com Logo
Airswift Sweden
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Behavioral Skills: analytical, communicates effectively, courage of conviction, manages risk
  • Functional Skills: emergency preparedness and response, incident investigation and analysis, operations integrity and compliance assessment, OIMS execution support, risk assessment and management, safety management, safety regulations and standards, fundamentals of health, fundamentals of environmental management and regulatory compliance, environmental standards, regulation development and advocacy, SSHE management - operations and maintenance, managing critical operations activities
  • Associate or Bachelor’s degree required
  • Demonstrated work experience in safety-related positions (including some prior oil & gas experience)
  • Knowledge of security processes and procedures
  • Proficient in use of computers and programs such as PowerPoint, Excel, Word and Microsoft Office
  • Read, write, and speak fluent English, as required to function effectively within a project team
Job Responsibility
Job Responsibility
  • Assist the workforce in the implementation of SSHE Processes, Safety Instructions, Safety Procedures, and hazard management strategies as well as ensure compliance with project plans and other relevant company programs
  • Encourage and facilitate an appropriate level of workforce participation in the application of SSHE processes
  • Proactively identify SSHE related issues at the project site and facilitate effective resolution of any issues
  • Participate in contractor qualification process and other SSHE activities as requested by SSHE Lead
  • Provide review and comment, as appropriate, on project specific procedures and manuals
  • Management, inspection and maintenance of SHE Critical Equipment (fire response, oil spill response, portable gas detection, life boats, life rafts, life vests etc.)
  • Review of annual ERT drill program and feedback to central OIMS team and System 10-2 Administrator. Communication of Emergency Response Plans to ERT and other relevant personnel
  • Coordination of emergency response teams in conjunction with On Scene Coordinator (OSC) during emergency scenarios. Manages forward control (FCP) during emergency situations
  • Fulltime
Read More
Arrow Right

Specialist II, Product Quality Assurance

The Specialist, NC Product Quality Assurance (PQA) will be responsible for suppo...
Location
Location
United States , Durham, NC
Salary
Salary:
105000.00 - 145000.00 USD / Year
beamtx.com Logo
Beam Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelors or Advanced degree in a scientific discipline
  • 10+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality
  • Knowledge of aseptic processing, and/or cell and gene therapy is preferred
  • Apply Quality concepts and company policies to resolve issues of moderate complexity in an effective manner
  • Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions
  • Knowledge of global regulations and standards
  • Strong team player that has a customer service approach and is solution oriented
  • Attention to detail and the ability to work individually as well as within a multi-disciplinary team
  • Excellent listening, communication and interpersonal skills with a team focus
  • Consistent delivery of high-quality work
Job Responsibility
Job Responsibility
  • Provide Quality oversight of on-the-floor activities including manufacturing shop floor presence during operations
  • Provide Quality oversight of QC testing
  • Responsible for ensuring GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations
  • Responsible for assisting with product disposition activities of supply produced at the manufacturing facility
  • Real time review of batch records and labels
  • Review and approval of manufacturing discrepancies and associated CAPA’s
  • Communicating lot disposition pending issues to management
  • Aid in the development and ongoing improvement of applicable quality systems for the site
  • identifying gaps or improvements, authoring and approval of procedures, and providing training, as needed
  • Review and approve calibration and maintenance work orders and asset inductions
  • Fulltime
Read More
Arrow Right

Compliance Analyst II

As a community, the University of Rochester is defined by a deep commitment to M...
Location
Location
United States of America , Rochester
Salary
Salary:
63815.00 - 95723.00 USD / Year
urmc.rochester.edu Logo
University of Rochester
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor or Associate’s degree in a related field preferred
  • Equivalent combination of education, professional certification(s), and substantial relevant experience will also be considered
  • Minimum of 3 years of healthcare coding experience required to include APG, APC, and/or DRG coding methodologies or professional coding and billing in specialty areas
  • Experience in a direct or supporting role within healthcare compliance preferably within an integrated health system or Academic Medical Center or other comparable setting
  • Strong communication, interpersonal, and public speaking skills required
  • Ability to efficiently produce clear, concise, and complete written audit reports required
  • Excellent analytical, organizational, and problem-solving skills required
  • Demonstrated objectivity and critical thinking in analyzing situations
  • must be able to evaluate facts without bias and avoid unsupported assumptions required
  • Ability to manage projects and effectively advise staff in a motivational and positive manner required
Job Responsibility
Job Responsibility
  • Provides compliance oversight and support for assigned clinical specialties across URMC and Affiliates in accordance with the OIG and OMIG compliance program guidance
  • Evaluates adherence to coding and billing regulations and guidelines through review, research, and analysis
  • Serves as a compliance resource, developing and delivering comprehensive education and training
  • Conducts investigations, risk assessments, and regulatory monitoring to prevent and detect fraud, waste, and abuse, specifically addressing the DRA, NY SSL § 363-d, and 18 NYCRR SubPart 521
  • Analyzes billing data to identify potential risk areas related to professional and/or facility payment systems
  • Performs audits of medical record documentation to ensure compliance with coding and billing requirements as defined by AMA, AHA, HCPCS, CMS and Medicaid guidelines
  • Creates and provides reports on findings to relevant stakeholders
  • Responds to reported compliance concerns by conducting formal investigative activities
  • Performs root cause analysis when deficiencies are identified
  • Collaborates with relevant stakeholders to determine improvement opportunities to mitigate future risk
  • Fulltime
Read More
Arrow Right

SPD Technician Floor Lead

The SPD Technician Floor Lead is accountable for the daily work flow and assignm...
Location
Location
United States , Madera
Salary
Salary:
26.65 - 37.90 USD / Hour
valleychildrens.org Logo
Valley Children's Healthcare
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School Diploma/G.E.D. (required)
  • CIS - Certified Instrument Specialist - HSPA - Healthcare Sterile Processing Association (required)
  • CRCST - Certified Registered Central Service Technician - HSPA - Healthcare Sterile Processing Association (required) Or CBSPDT - Certified Sterile Processing and Distribution Technician - Certified Board of Sterile Processing and Distribution (required)
  • Minimum five (5) years A minimum of 5 years progressively responsible experience, which includes specialty instrumentation, devices, and equipment. (preferred)
  • Excellent verbal and written communication skills, and knowledge of instrumentation, medical devices, and endoscopes.
  • Computer Skills Demonstrates proficiency in computer skills.
Job Responsibility
Job Responsibility
  • Accountable for the daily work flow and assignments of Tech I, Tech II, and Tech III staff, to ensure cleaning, inspecting, assembly, high-level disinfection, and/or sterilization of all instrumentation, medical devices, and flexible endoscopes for the hospital.
  • Responsible for accurately entering data into an instrument tracking system.
  • Follows departmental policies, processes, and regulatory requirements.
  • Fulltime
Read More
Arrow Right